Cleared Traditional

MALE CIRCUMCISION KITS:RAPIDECLAMP

K142163 · Medicfit Technology Sdn Bhd · Obstetrics & Gynecology
Apr 2015
Decision
257d
Days
Class 2
Risk

About This 510(k) Submission

K142163 is an FDA 510(k) clearance for the MALE CIRCUMCISION KITS:RAPIDECLAMP, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Medicfit Technology Sdn Bhd (Great Neck, US). The FDA issued a Cleared decision on April 20, 2015, 257 days after receiving the submission on August 6, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K142163 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2014
Decision Date April 20, 2015
Days to Decision 257 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HFX — Clamp, Circumcision
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530