Product Code: HFX FDA class 2 21 CFR 884.4530

Clamp, Circumcision

Obstetrics/Gynecology

The Circumcision Clamp is a surgical device used to hold the foreskin in place and provide a guide for excision during neonatal or adult circumcision procedures, helping to control bleeding and ensure a uniform resection. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFX, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: HFX
Device Class: FDA class 2
Regulation Number: 884.4530
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251687	Konig Bell Circumcision Clamp	Feb 25, 2026	Substantially Equivalent	Medline Industries, LP
K221356	Wee Bell	Feb 02, 2023	Substantially Equivalent	Wee Medical
K212911	Konig Mogen Clamp	Nov 18, 2022	Substantially Equivalent	Medline Industries, Inc.
K151095	Circumplast Circumcision Device	Sep 18, 2015	Substantially Equivalent	Novadien Healthcare
K142163	MALE CIRCUMCISION KITS:RAPIDECLAMP	Apr 20, 2015	Substantially Equivalent	Medicfit Technology Sdn Bhd
K131373	SHANGRING	Jun 25, 2013	Substantially Equivalent	Wuhu Snnda Medical Treatment Appliance Technology
K121789	SHANGRING	Aug 03, 2012	Substantially Equivalent	Wuhu Snna Medical Treatment Appliance Technology C
K103695	PREPEX SYSTEM	Jan 10, 2012	Substantially Equivalent	Circ Medtech
K100916	MEDICON MOGEN CLAMP	Dec 06, 2010	Substantially Equivalent	Medicon EG
K061539	GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE	Sep 20, 2007	Substantially Equivalent	Clinical Innovations, LLC
K063429	GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200	Jan 17, 2007	Substantially Equivalent	Generic Medical Device, Inc.
K043533	SURGICAL DESIGN CIRCUMCISION CLAMP	Apr 01, 2005	Substantially Equivalent	Surgical Design, Inc.
K040052	FINE SURGICAL CIRCUMCISION CLAMP	Apr 09, 2004	Substantially Equivalent	Fine Surgical Instrument Corp.
K032091	SMART KLAMP VARIOUS BY SIZE	Mar 08, 2004	Substantially Equivalent	Emergogroup, Inc.
K033403	T.S. MEDICAL CIRCUMCISION CLAMP	Jan 22, 2004	Substantially Equivalent	T.S. Medical
K010867	KILEJIAN CIRCUMCISOR	May 03, 2001	Substantially Equivalent	Iris Surgical, LLC
K974286	CIRCUMCISION TRAY, CAT. NO. 70340	Dec 12, 1997	Substantially Equivalent	Trinity Laboratories, Inc.
K970282	MEDLINE CIRCUMCISION TRAY	Mar 06, 1997	Substantially Equivalent	Medline
K945949	KILEJIAN CIRCUMCISION TEMPLATE [THE DOME]	Jul 25, 1995	Substantially Equivalent	Vlm Surgical, Inc.
K935697	CIRCUMCISION TRAY	May 02, 1994	Unknown	Cush Medical Products
K926535	GOMCO CIRCUMCISION CLAMP	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K926471	MOGAN CIRCUMCISION CLAMP	Feb 25, 1994	Substantially Equivalent	Thomasville Medical Assoc.
K935491	CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)	Feb 17, 1994	Substantially Equivalent	Tri-State Hospital Supply Corp.
K900370	ONE/CIRC (CIRCUMCISION CLAMP)	Apr 16, 1990	Substantially Equivalent	Bionix Development Corp.
K894201	GOMCO CIRCUMCISION CLAMP	Aug 11, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K890897	CENTURION CIRCLAMP	Mar 28, 1989	Substantially Equivalent	Tri-State Hospital Supply Corp.
K884290	BAXTER DISPOSABLE CIRCUMCISION TRAY	Dec 08, 1988	Unknown	Baxter Healthcare Corp