Panels › Obstetrics/Gynecology › Product code KNH · Class 3
Laparoscopic Contraceptive Tubal Occlusion Device
Regulation 884.5380
0510(k)s in 12 months (0 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in KNH
| Company | 510(k)s | Recalls |
|---|---|---|
| Gyrus Medical, Inc | 0 | 2 |
| Gyrus Acmi, Incorporated | 0 | 1 |
| Richard Wolf Medical Instruments Corp. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a st Terminated |
KNH | None listed |
| Nov 6, 2014 | Richard Wolf Medical Instruments Corp. The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouc Terminated |
KNH | None listed |
| Aug 19, 2014 | Gyrus Medical, Inc Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB Terminated |
KNH | None listed |
| Mar 13, 2014 | Gyrus Medical, Inc Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only.
The disposable Falope-Ring Band Applicator is Terminated |
KNH | None listed |
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