# K073182: Gyn Disposables Tenaculum 356T

- Pathway: 510(k) (Traditional)
- Applicant: Gyn-Disposables, Inc.
- Decided: Nov 28, 2007 after 15 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890379 (1989). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930037: Atraumatic Tenacula, Thomasville Medical Assoc. (1994) Summary page 2.
- K980247: Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum, Gynex Corp. (1998) Summary page 2.

## Most influential descendants
- K203820: ASPIVIX  v1.1 Cervical Suction Tenaculum (2021), 1 descendant of its own
- K223866: Carevix™ Suction Cervical Stabilizer (2023), 0 descendants of its own

## Recalls of this device
- Sep 10, 2021 · Class II · Z-0128-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Sep 10, 2021 · Class II · Z-0126-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Sep 10, 2021 · Class II · Z-0127-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Sep 10, 2021 · Class II · Z-0129-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Sep 10, 2021 · Class II · Z-0130-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Sep 10, 2021 · Class II · Z-0131-2022: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Jul 29, 2011 · Not classified · Z-3025-2011: Lack of sterility assurance.

## Indications for use
Snare, grasp, hold and manipulate cervical and intravaginal tissue.

Source page: https://510kreport.com/device/K073182
Methodology: https://510kreport.com/methodology