Genzyme Surgical Product (Genzyme Biosurgery)
Country not established
- Devices
- 9
What Genzyme Surgical Product (Genzyme Biosurgery) makes
Genzyme Surgical Product manufactures a range of surgical sutures, including absorbable options like polyglycolic acid sutures (Bondek, Bondek Plus) and nonabsorbable variants such as nylon, polyester (Dacron, Polydek, Tevdek), and silk sutures. Their portfolio also includes cardiovascular valve sutures (NextStitch), a saphenous vein lifter (Saphlift), blood bag transfer systems (Rapid Transfer Blood Bag models), and endoscopic camera accessories (Millennium Valve Introducer/Rotator Handle).
The company’s devices are classified under FDA categories Class I and Class II, with regulatory clearance supported through 510(k) submissions. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Nextstitch Cardiovascular Valve Suture Ref K001440
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Saphlift Ref K990062
Regimes: 510(k) Registry: 510(k)Cutalon Nylon Polyamide Surgical Suture Ref K981322
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
'cottony' Ii Dacron, Silky Ii Polydek & Tevdek Ii Polyester Nonabsorbable Surgical Suture Ref K001434
Regimes: 510(k) Registry: 510(k)Endoscopic Camera Ref K991416
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Millennium Valve Introducer/Rotator Handle Ref K980016
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genzyme Surgical Product (Genzyme Biosurgery) have in the registry?
The registry currently lists 9 devices for Genzyme Surgical Product (Genzyme Biosurgery). Devices recorded under merged duplicate company entries are counted once.
Which registries list Genzyme Surgical Product (Genzyme Biosurgery)'s devices?
Among its 9 most recently registered devices, Genzyme Surgical Product (Genzyme Biosurgery) has devices listed in FDA 510(k) (9 devices).
What risk classes do Genzyme Surgical Product (Genzyme Biosurgery)'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Genzyme Surgical Product (Genzyme Biosurgery)'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genzyme Surgical Product (Genzyme Biosurgery) in the registry?
The most recently registered devices listed for Genzyme Surgical Product (Genzyme Biosurgery) include NEXTSTITCH CARDIOVASCULAR VALVE SUTURE, RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250, SAPHLIFT and CUTALON NYLON POLYAMIDE SURGICAL SUTURE.