Genzyme Biosurgery
Country not established
- Devices
- 5
What Genzyme Biosurgery makes
Genzyme Biosurgery manufactures surgical devices including a continuous reinfusion autotransfusion system for pleural drainage, a tissue retractor system for surgical exposure, synthetic absorbable sutures for internal wound closure, ligating loops for vascular and tubular structures, and silk sutures for general surgical use.
The company’s portfolio includes devices classified as Class II and Class III under US regulations, with submissions recorded via FDA 510(k) clearances and PMA authorisations. These products are listed in the US regulatory database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Radlite Tissue Retractor System Ref K022989
Regimes: 510(k) Registry: 510(k)Monodek Synthetic Absorbable Surgical Suture Ref K030212
Regimes: 510(k) Registry: 510(k)Saph-Loop Ligating Loop Ref K022410
Regimes: 510(k) Registry: 510(k)Prevelle Silk Ref P030032
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Genzyme Biosurgery have in the registry?
The registry currently lists 5 devices for Genzyme Biosurgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genzyme Biosurgery's devices?
Among its 5 most recently registered devices, Genzyme Biosurgery has devices listed in FDA 510(k) (4 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Genzyme Biosurgery's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Genzyme Biosurgery's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Genzyme Biosurgery in the registry?
The most recently registered devices listed for Genzyme Biosurgery include S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM, RADLITE TISSUE RETRACTOR SYSTEM, MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE and SAPH-LOOP LIGATING LOOP.