# K980247: Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum

- Pathway: 510(k) (Traditional)
- Applicant: Gynex Corp.
- Decided: Mar 17, 1998 after 53 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890379 (1989). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890379: Uterine Tentaculum, Kinetic Medical Products (1989) Summary page 2.
- K891349: Campion Cervical Hook, Simpson/Basye, Inc. (1989) Summary page 2.
- K891033: Atraumatic Tenacula, Zinnanti Surgical Instruments, Inc. (1989). Our OCR of the scanned summary read K890133, FDA’s number for Ocular Connection Machine (TM) (Innovision Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Zinnanti Atraumatic Tenacula”. Summary page 3.
- (no number) Emmett Tenaculum Hooks, V. Mueller: named in the summary without a submission number

## Most influential descendants
- K073182: Gyn Disposables Tenaculum 356T (2007), 2 descendants of its own
- K203820: ASPIVIX  v1.1 Cervical Suction Tenaculum (2021), 1 descendant of its own
- K223866: Carevix™ Suction Cervical Stabilizer (2023), 0 descendants of its own

## Indications for use
GYNEX Tenaculum - Grasp/manipulate the cervix & soft tissue GYNEX Iris Hook - Grasp/manipulate cervical tissue GYNEX Angle Hook - Grasp/manipulate cervical tissue

Source page: https://510kreport.com/device/K980247
Methodology: https://510kreport.com/methodology