510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061539Substantially Equivalent

Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device

Clinical Innovations, LLC, Murray UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K061539 is the FDA 510(k) clearance record for GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE, a class II device, cleared for Clinical Innovations, LLC on under FDA product code HFX (Clamp, Circumcision). FDA records list 18 510(k) clearances for Clinical Innovations, LLC, from to . As of , FDA records show no recalls naming K061539.

Clearance record

Decision date
Received
(472 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Clinical Innovations, LLC 747 W 4170 S, Murray UT
510(k) summary
Statement
Third party review
No

Clearances, product code HFX

Trailing 12 months
1 clearance under product code HFX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260