Island Biosurgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Island Biosurgical, Inc. makes
Island Biosurgical, Inc. manufactures surgical kits and bolster devices used in urological procedures, including bladder neck bolster systems and related surgical accessories for minimally invasive applications.
The company’s portfolio is classified under FDA Class II devices and is authorised via 510(k) clearances. Products are listed in the FDA’s 510(k) registry, with the company headquartered in the United States.
Catalogue
Island Biosurgical Bns Kit #3 Ref K001583
Regimes: 510(k) Registry: 510(k)Island Biosurgical Bolster Ref K960101
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Island Biosurgical Inc. Bns Kit #1 & #2 Ref K973022
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Island Biosurgical, Inc. have in the registry?
The registry currently lists 4 devices for Island Biosurgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Island Biosurgical, Inc.'s devices?
Among its 4 most recently registered devices, Island Biosurgical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Island Biosurgical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Island Biosurgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Island Biosurgical, Inc. in the registry?
The most recently registered devices listed for Island Biosurgical, Inc. include ISLAND BIOSURGICAL BNS KIT #3, ISLAND BIOSURGICAL BOLSTER, ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 and ISLAND BIOSURGICAL INC. BNS KIT #1 & #2.