Gyneco, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Gyneco, Inc. makes
Gyneco, Inc. manufactures instruments for gynecological and cardiac procedures, including cervical biopsy tools like the GYNE-SHEAR with disposable tip, fine needle aspiration devices, and endometrial biopsy kits with plastic curettes. The company also produces temporary cardiac pacing wires, such as the SYNCARE pacing wire, designed for short-term use in cardiac interventions.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, reflecting their authorised status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Endocyte Ref K843941
Regimes: 510(k) Registry: 510(k)Fine Needle Aspiration Device Ref K841275
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Syncare Temporary Cardiac Pacing Wire Ref K861409
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gyneco, Inc. have in the registry?
The registry currently lists 5 devices for Gyneco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gyneco, Inc.'s devices?
Among its 5 most recently registered devices, Gyneco, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Gyneco, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Gyneco, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gyneco, Inc. in the registry?
The most recently registered devices listed for Gyneco, Inc. include GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP, ENDOCYTE, FINE NEEDLE ASPIRATION DEVICE and MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3, 4MM-4003, 4.