SURGICAL DESIGN CIRCUMCISION CLAMP— 510(k) K043533

Name: FDA 510(k) clearance K043533
Creator: U.S. Food and Drug Administration
Published: 2005-04-01

Substantially Equivalent

Surgical Design, Inc.

FDA 510(k) clearance K043533 for SURGICAL DESIGN CIRCUMCISION CLAMP, Substantially Equivalent on 2005-04-01. Applicant: Surgical Design, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Design, Inc.
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2004-12-22
Decision date: 2005-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lorton, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFX

view all

K251687 — Konig Bell Circumcision Clamp2026-02-25
K221356 — Wee Bell2023-02-02
K212911 — Konig Mogen Clamp2022-11-18
K151095 — Circumplast Circumcision Device2015-09-18
K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP2015-04-20

Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.