# K172661: Fetzer Medical Gynecological Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Fetzer Medical GmbH & Co. KG
- Decided: May 8, 2018 after 245 days
- Product code: HCZ (Forceps, Surgical, Gynecological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K092840 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134047: Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical Forceps, Integra LifeSciences Corporation (2014) Summary page 4.

## Recalls of this device
- Dec 28, 2018 · Class II · Z-0756-2019: The firm had a report of doctors being unable to pull the obstetric forceps apart.
- Dec 28, 2018 · Class II · Z-0755-2019: The firm had a report of doctors being unable to pull the obstetric forceps apart.
- Dec 28, 2018 · Class II · Z-0757-2019: The firm had a report of doctors being unable to pull the obstetric forceps apart.
- Dec 28, 2018 · Class II · Z-0758-2019: The firm had a report of doctors being unable to pull the obstetric forceps apart.

## Indications for use
Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

Source page: https://510kreport.com/device/K172661
Methodology: https://510kreport.com/methodology