GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE— 510(k) K061539

Name: FDA 510(k) clearance K061539
Creator: U.S. Food and Drug Administration
Published: 2007-09-20

Substantially Equivalent

Clinical Innovations, LLC

FDA 510(k) clearance K061539 for GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE, Substantially Equivalent on 2007-09-20. Applicant: Clinical Innovations, LLC. Device class: 2.

Clearance details

Applicant: Clinical Innovations, LLC
Product code: Code HFX
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2006-06-05
Decision date: 2007-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray, UT, 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

More clearances from Clinical Innovations, LLC

view all

K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) +3 more2025-10-08
K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E)2025-05-22
K223900 — babyLance Safety Heelstick (BLM, BLN, BLP)2023-02-24
K153591 — ebb Complete Tamponade System2016-01-14
K150573 — ebb Complete Tamponade System2015-03-25

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.