SOLOS ENDOSCOPY, INC.

Address:1698 Post Road E,Westport,CT,06880,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Laparoscope, Gynecologic (And Accessories) (HET) (8) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2)

Premarket Exempt

Clear

SOLOS - 00862311000489 Catalog Number :

Device Description : 5mm Grasping Forcep, Monopolar Handle w/Rotation

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00862311000496 Catalog Number :

Device Description : 10mm Glassman Forcep, Ratcheting Handle

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000305 Catalog Number :

Device Description : Curved Dissector, 5mm, Rotatable

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000312 Catalog Number :

Device Description : Glassman Clamp, 5mm, 20mm jaw,

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000329 Catalog Number :

Device Description : Glassman Clamp, 5mm, 40mm jaw

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000336 Catalog Number :

Device Description : Right Angled Dissector, 10mm

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000343 Catalog Number :

Device Description : Spatula Suction Coagulator, 5mm

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000350 Catalog Number :

Device Description : Hook Suction Coagulator

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000367 Catalog Number :

Device Description : Glassman Type Clamp, 40mm jaw

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SOLOS - 00866370000374 Catalog Number :

Device Description : Right Angle Dissector, 90 degree

Device Class : 2

Duns Number: 625281332

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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