510(k) K073182 ยท HDC Tenaculum, Uterine
GYN DISPOSABLES TENACULUM 356T
| Applicant | Gyn-Disposables, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 28, 2007 |
| Received | Nov 13, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Tenaculum, Plastic Open, Classified |
HDC | None listed |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare IUD Insertion Pack Open, Classified |
HDC | None listed |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare IUD Insertion Kit Open, Classified |
HDC | None listed |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Endometrial Biopsy Kit Open, Classified |
HDC | None listed |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Foundation Kit Open, Classified |
HDC | None listed |
| Sep 10, 2021 | Stradis Medical, LLC dba Stradis Healthcare Standard IUD Insertion Kit Open, Classified |
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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.