# K043533: Surgical Design Circumcision Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Design, Inc.
- Decided: Apr 1, 2005 after 100 days
- Product code: HFX (Clamp, Circumcision)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890897 (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)
- K890897: Centurion Circlamp, Tri-State Hospital Supply Corp. (1989) Summary page 1.

## Recalls of this device
- Jan 26, 2011 · Not classified · Z-2153-2011: Medical device used in surgical procedure is defective and may break during use.

## Indications for use
A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.

Source page: https://510kreport.com/device/K043533
Methodology: https://510kreport.com/methodology