Gerard Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Gerard Medical, Inc. makes
Gerard Medical, Inc. manufactures surgical instruments for minimally invasive procedures, including a catheter tunneler for subcutaneous placement, a trimport device for multi-lumen access, an endo-needle instrument for tissue manipulation, and a hernia mesh introduction system for laparoscopic repairs.
The company’s products are regulated under FDA Class I and Class II classifications, with most devices authorised via the 510(k) pathway. They are listed in the FDA’s 510(k) database and operate from the United States.
Catalogue
Catheter Tunneler Ref K972555
Regimes: 510(k) Registry: 510(k)Trimport Ref K974533
Regimes: 510(k) Registry: 510(k)Endo-Needle Instrument Ref K936207
Regimes: 510(k) Registry: 510(k)Hernia Mesh Introduction System Ref K945060
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gerard Medical, Inc. have in the registry?
The registry currently lists 4 devices for Gerard Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gerard Medical, Inc.'s devices?
Among its 4 most recently registered devices, Gerard Medical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Gerard Medical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gerard Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gerard Medical, Inc. in the registry?
The most recently registered devices listed for Gerard Medical, Inc. include CATHETER TUNNELER, TRIMPORT, ENDO-NEEDLE INSTRUMENT and HERNIA MESH INTRODUCTION SYSTEM.