Cleared Traditional

K100916 - MEDICON MOGEN CLAMP

K100916 is an FDA 510(k) clearance for MEDICON MOGEN CLAMP, manufactured by Medicon EG. The device is a Class 2 Obstetrics & Gynecology device with product code HFX cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K100916 · Medicon EG · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
248d
Days
Class 2
Risk

K100916 is an FDA 510(k) clearance for the MEDICON MOGEN CLAMP. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on December 6, 2010 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K100916

510(k) Number K100916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2010
Decision Date December 06, 2010
Days to Decision 248 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
87d slower than avg
Panel avg: 161d · This submission: 248d
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 23
Devices cleared under the same product code (HFX) and FDA review panel - the closest regulatory comparables to K100916.
SHANGRING
K131373 · Wuhu Snnda Medical Treatment Appliance Technology · Jun 2013
SHANGRING
K121789 · Wuhu Snna Medical Treatment Appliance Technology C · Aug 2012
PREPEX SYSTEM
K103695 · Circ Medtech · Jan 2012
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
K061539 · Clinical Innovations, LLC · Sep 2007
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K063429 · Generic Medical Device, Inc. · Jan 2007
SURGICAL DESIGN CIRCUMCISION CLAMP
K043533 · Surgical Design, Inc. · Apr 2005