Panels › Obstetrics/Gynecology › Product code HEE · Class 2
Set, Anesthesia, Paracervical
Regulation 884.5100
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HEE
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 2 | 1 |
| A & A Medical, Inc. | 1 | 0 |
| Avid Medical, Inc. | 1 | 0 |
| Ellman Intl., Inc. | 1 | 0 |
| Gynex Corp. | 1 | 0 |
| Ri Mos. S.R.L. | 1 | 0 |
| Rocket Medical Plc | 1 | 0 |
| Wallach Surgical Devices, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2015 | CooperSurgical, Inc. CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure
P/N 6061 Terminated |
HEE | K910253 |
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