510(k) Report

FDA applicant

Gyn-Disposables, Inc.

Memphis, TN1 decision2007–20077 recalls

FDA records 1 decision for Gyn-Disposables, Inc. (Memphis, TN) in 2007: 1 510(k) clearance. All are in product code HDC (Tenaculum, Uterine). Its devices cite 2 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Gyn-Disposables, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

6in 2021

2011: 12021: 6
2007high 6 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gyn-Disposables, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gyn-Disposables, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HDCTenaculum, Uterine1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K073182Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 20071cites it

What has FDA decided for it lately?

  • K073182Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 20077 recalls

The one decision as Gyn-Disposables, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K073182IUD Insertion KitSep 10, 2021Class II
  • K073182Tenaculum, PlasticSep 10, 2021Class II
  • K073182IUD Insertion PackSep 10, 2021Class II
  • K073182Endometrial Biopsy KitSep 10, 2021Class II
  • K073182Foundation KitSep 10, 2021Class II
  • K073182Standard IUD Insertion KitSep 10, 2021Class II