Nu-Gyn-Tek, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Nu-Gyn-Tek, Inc. makes
Nu-Gyn-Tek, Inc. manufactures medical devices including THE D & C PAD-SAC and POLY-OP (TM), which are used in gynecological procedures.
The company's devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Nu-Gyn-Tek, Inc. is based in the US.
Catalogue
The D & C Pad-Sac Ref K862297
Regimes: 510(k) Registry: 510(k)Poly-Op (Tm) Ref K900759
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nu-Gyn-Tek, Inc. have in the registry?
The registry currently lists 2 devices for Nu-Gyn-Tek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nu-Gyn-Tek, Inc.'s devices?
Among its 2 most recently registered devices, Nu-Gyn-Tek, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Nu-Gyn-Tek, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nu-Gyn-Tek, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nu-Gyn-Tek, Inc. in the registry?
The most recently registered devices listed for Nu-Gyn-Tek, Inc. include THE D & C PAD-SAC and POLY-OP (TM).