# K063429: GMD Universal Circumcision Clamp, Model 200

- Pathway: 510(k) (Traditional)
- Applicant: Generic Medical Device, Inc.
- Decided: Jan 17, 2007 after 65 days
- Product code: HFX (Clamp, Circumcision)
- 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 K894201 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894201: Gomco Circumcision Clamp, Zinnanti Surgical Instruments, Inc. (1989) Summary page 1.

## Indications for use
The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Source page: https://510kreport.com/device/K063429
Methodology: https://510kreport.com/methodology