Biosurge, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Biosurge, Inc. makes
Biosurge, Inc. manufactures medical devices designed to reduce tissue adhesion and improve surgical outcomes, including the BIOSURGE Model ILVC-1, ASD-Bio Anti-Stick Device, BIOSURGE Model OASYS-II, ASD Single Lumen Needle, and BIOSURGE Model OASYS. These products are intended for use in laparoscopic and minimally invasive procedures to minimize postoperative adhesions and complications. The portfolio also includes specialized needles and barriers to protect surgical sites during procedures.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance obtained through the 510(k) pathway. Products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. Biosurge, Inc. is headquartered in the US.
Catalogue
Biosurge Model Ilvc-1 Ref K875016
Regimes: 510(k) Registry: 510(k)Asd-Bio Anti-Stick Device Ref K874602
Regimes: 510(k) Registry: 510(k)Biosurge Model Oasys-Ii Ref K875023
Regimes: 510(k) Registry: 510(k)Asd Single Lumen Needle Ref K884620
Regimes: 510(k) Registry: 510(k)Biosurge Model Oasys Ref K871258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosurge, Inc. have in the registry?
The registry currently lists 5 devices for Biosurge, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosurge, Inc.'s devices?
Among its 5 most recently registered devices, Biosurge, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Biosurge, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Biosurge, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosurge, Inc. in the registry?
The most recently registered devices listed for Biosurge, Inc. include BIOSURGE MODEL ILVC-1, ASD-BIO ANTI-STICK DEVICE, BIOSURGE MODEL OASYS-II and ASD SINGLE LUMEN NEEDLE.