Panels › Obstetrics/Gynecology › Product code HDC · Class 2
Tenaculum, Uterine
Regulation 884.4530
0510(k)s in 12 months (20 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in HDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Stradis Medical, LLC dba Stradis Healthcare | 0 | 6 |
| Simpson/Basye, Inc. | 3 | 0 |
| Aspivix SA | 2 | 0 |
| Gyn-Disposables, Inc. | 1 | 1 |
| Ron-Tech Medical , Ltd. | 2 | 0 |
| Vascular Control Systems, Inc. | 2 | 0 |
| Bioceptive, Inc. | 1 | 0 |
| Commercial Products & Engineering Co. | 1 | 0 |
| Fem Suite, LLC | 1 | 0 |
| Gynex Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Standard IUD Insertion Kit Open, Classified |
HDC | K073182 |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Foundation Kit Open, Classified |
HDC | K073182 |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Endometrial Biopsy Kit Open, Classified |
HDC | K073182 |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare IUD Insertion Kit Open, Classified |
HDC | K073182 |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare IUD Insertion Pack Open, Classified |
HDC | K073182 |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Tenaculum, Plastic Open, Classified |
HDC | K073182 |
| Dec 16, 2014 | Instrumed International, Inc. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names.
A uterine tenaculum is a hook-like Terminated |
HDC | None listed |
| Aug 15, 2011 | GYN Disposables Inc GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1,
GYN Terminated |
HDC | K073182 |
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