Asensus Surgical, Inc.

Address:1 TW Alexander Drive, Suite 160,Durham,NC,27703,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

System, Surgical, Computer Controlled Instrument (NAY) (4) Camera, Television, Endoscopic, With Audio (FWG) (1)

Premarket Exempt

No Yes

Clear

Senhance - 00815440021931 Catalog Number :

Device Description : Senhance Intelligent Surgical Unit

Device Class : 2

Duns Number: 969118900

Premarket Exempt : No

Product Code : NAY

Prescription Use : Yes

Device Count : 1

Senhance - 00815440022075 Catalog Number :

Device Description : Senhance Manipulator Arm, ISU Configuration

Device Class : 2

Duns Number: 969118900

Premarket Exempt : No

Product Code : NAY

Prescription Use : Yes

Device Count : 1

Senhance - 00815440022082 Catalog Number :

Device Description : Senhance Cockpit, ISU Configuration

Device Class : 2

Duns Number: 969118900

Premarket Exempt : No

Product Code : NAY

Prescription Use : Yes

Device Count : 1

Senhance - 00815440022228 Catalog Number : X9007741

Device Description : Senhance Connect

Device Class : 1

Duns Number: 969118900

Premarket Exempt : Yes

Product Code : FWG

Prescription Use : Yes

Device Count : 1

Senhance - 00815440022280 Catalog Number : X9007775

Device Description : Karl Storz 3D4K 10mm Endoscope Adapter

Device Class : 2

Duns Number: 969118900

Premarket Exempt : No

Product Code : NAY

Prescription Use : Yes

Device Count : 1

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