510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K142163Substantially Equivalent

Male Circumcision Kits:rapideclamp

Medicfit Technology Sdn Bhd, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142163 is the FDA 510(k) clearance record for MALE CIRCUMCISION KITS:RAPIDECLAMP, a class II device, cleared for Medicfit Technology Sdn Bhd on under FDA product code HFX (Clamp, Circumcision). FDA records list one 510(k) clearance for Medicfit Technology Sdn Bhd. As of , FDA records show no recalls naming K142163.

Clearance record

Decision date
Received
(257 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medicfit Technology Sdn Bhd 55 Northern Blvd., Great Neck NY
510(k) summary
Summary PDF
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