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

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.

Clearance details

Applicant: Clinical Innovations, LLC
Product code: Code HFX
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 ↗

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.