Panels › Obstetrics/Gynecology › Product code KOH · Class 1
Instrument, Manual, General Obstetric-Gynecologic
Regulation 884.4520
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in KOH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 3 | 0 |
| Medikmark, Inc. | 2 | 0 |
| American V. Mueller | 1 | 0 |
| Boston Scientific Corporation | 0 | 1 |
| C. Intl. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Imm Enterprises , Ltd. | 1 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 0 |
| M. Joel Gebhart, D.D.S. | 1 | 0 |
| Ob/Gyn Concepts, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2021 | Boston Scientific Corporation Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure.
Material No. Open, Classified |
KOH | None listed |
| Jun 12, 2003 | Portex, Inc Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40. Terminated |
KOH | K894613 K894614 +1 |
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