Gyn-Disposables, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Gyn-Disposables, Inc. makes
Gyn-Disposables, Inc. manufactures single-use tenacula, including the GYN DISPOSABLES TENACULUM 356T, designed for gynecological surgical procedures.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Gyn Disposables Tenaculum 356T Ref K073182
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Gyn-Disposables, Inc., initiated on 2011-07-29. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 29 Jul 2011 Z-3025-2011 Unclassified (pre-2012) Terminated Lack of sterility assurance.
Frequently asked questions
How many devices does Gyn-Disposables, Inc. have in the registry?
The registry currently lists 1 device for Gyn-Disposables, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gyn-Disposables, Inc.'s devices?
Among its 1 most recently registered device, Gyn-Disposables, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Gyn-Disposables, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gyn-Disposables, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gyn-Disposables, Inc.?
FDA recall records list 1 recall initiated by Gyn-Disposables, Inc., the most recent initiated on 29 Jul 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Gyn-Disposables, Inc. in the registry?
The most recently registered devices listed for Gyn-Disposables, Inc. include GYN DISPOSABLES TENACULUM 356T.