Cleared Traditional

K063429 - GMD UNIVERSAL CIRCUMCISION CLAMP

K063429 is an FDA 510(k) clearance for GMD UNIVERSAL CIRCUMCISION CLAMP, manufactured by Generic Medical Device, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K063429 · Generic Medical Device, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
65d
Days
Class 2
Risk

K063429 is an FDA 510(k) clearance for the GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Generic Medical Device, Inc. (Houston, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Generic Medical Device, Inc. devices

FDA 510(k) Submission Details - K063429

510(k) Number K063429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date January 17, 2007
Days to Decision 65 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 160d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFX Device Classification - Class 2, Special Controls

Product Code HFX Clamp, Circumcision
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFX Clamp, Circumcision

All 8
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K063429.
Konig Bell Circumcision Clamp
K251687 · Medline Industries, LP · Feb 2026
Wee Bell
K221356 · Wee Medical · Feb 2023
Konig Mogen Clamp
K212911 · Medline Industries, Inc. · Nov 2022
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · Trinity Laboratories, Inc. · Dec 1997
MOGAN CIRCUMCISION CLAMP
K926471 · Thomasville Medical Assoc. · Feb 1994
GOMCO CIRCUMCISION CLAMP
K926535 · Thomasville Medical Assoc. · Feb 1994