Ovesco Endoscopy AG

Address:Friedrich-Miescher-Strasse 9,Tuebingen Baden-Wurttemberg,DE

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- Catalog Number : 200.53.02

Device Description : The AqaNife is a monopolar electrosurgical instrument for dissection using flexi The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.53.03

Device Description : The AqaNife is a monopolar electrosurgical instrument for dissection using flexi The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.53.04

Device Description : The AqaNife is a monopolar electrosurgical instrument for dissection using flexi The AqaNife is a monopolar electrosurgical instrument for dissection using flexible endoscopes • precise marking of tissue • stable position of the needle without risk of dislocating during the dissection • ceramic socket as stopper and protector • opening in the ceramic socket for flushing and re-injection

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.76

Device Description : The diagnostic FTRD Set is a novel tool for diagnostic and therapeutic full-thic The diagnostic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • enables a thorough pathological examination of e.g. motility disorders (e.g. Morbus Hirschsprung) • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: diagnostic FTRD (application cap with preloaded clip and integrated HF snare endoscope sleeve, hand wheel and thread retriever for colonoscopes) • FTRD Marking Probe (HF coagulation probe marking of the target lesion in preparation of FTRD use for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps proper grip on the target tissue precise retrieval of the sample into the application cap of the FTRD)

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : OCZ, KNS, FDI, PKL

Prescription Use : Yes

Device Count : 1

Device Description : The stentfix OTSC System Set consists of a clip preloaded onto an application ca The stentfix OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL, OCZ

Prescription Use : Yes

Device Count : 1

Device Description : The mini OTSC System extends the OTSC System by a smaller size • it can be use The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

Device Description : The mini OTSC System extends the OTSC System by a smaller size • it can be use The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

Device Description : FTRD application cap for verification of possible application of the colonic FTR FTRD application cap for verification of possible application of the colonic FTRD (accessability and ability to pull lesion into the cap).

Device Class : 1

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : FEI

Prescription Use : Yes

Device Count : 1

Device Description : FTRD application cap for verification of possible application of the gastroduode FTRD application cap for verification of possible application of the gastroduodenal FTRD® Set and diagnostic FTRD® Set (accessability and ability to pull lesion into the cap).

Device Class : 1

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : FEI

Prescription Use : Yes

Device Count : 1

Device Description : The mini OTSC System extends the OTSC System by a smaller size • it can be use The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1