HFX · Class II · 21 CFR 884.4530

FDA Product Code HFX: Clamp, Circumcision

Leading manufacturers include Thomasville Medical Assoc., Medicfit Technology Sdn Bhd and Novadien Healthcare.

27
Total
27
Cleared
179d
Avg days
1988
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 268d recently vs 175d historically

FDA 510(k) Cleared Clamp, Circumcision Devices (Product Code HFX)

27 devices
1–24 of 27
Cleared Feb 25, 2026
Konig Bell Circumcision Clamp
K251687
Medline Industries, LP
Obstetrics & Gynecology · 268d
Cleared Feb 02, 2023
Wee Bell
K221356
Wee Medical
Obstetrics & Gynecology · 268d
Cleared Nov 18, 2022
Konig Mogen Clamp
K212911
Medline Industries, Inc.
Obstetrics & Gynecology · 431d
Cleared Sep 18, 2015
Circumplast Circumcision Device
K151095
Novadien Healthcare
Obstetrics & Gynecology · 148d
Cleared Apr 20, 2015
MALE CIRCUMCISION KITS:RAPIDECLAMP
K142163
Medicfit Technology Sdn Bhd
Obstetrics & Gynecology · 257d
Cleared Jun 25, 2013
SHANGRING
K131373
Wuhu Snnda Medical Treatment Appliance Technology
Obstetrics & Gynecology · 43d
Cleared Aug 03, 2012
SHANGRING
K121789
Wuhu Snna Medical Treatment Appliance Technology C
Obstetrics & Gynecology · 45d
Cleared Jan 10, 2012
PREPEX SYSTEM
K103695
Circ Medtech
Obstetrics & Gynecology · 389d
Cleared Dec 06, 2010
MEDICON MOGEN CLAMP
K100916
Medicon EG
Obstetrics & Gynecology · 248d
Cleared Sep 20, 2007
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
K061539
Clinical Innovations, LLC
Obstetrics & Gynecology · 472d
Cleared Jan 17, 2007
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K063429
Generic Medical Device, Inc.
Obstetrics & Gynecology · 65d
Cleared Apr 01, 2005
SURGICAL DESIGN CIRCUMCISION CLAMP
K043533
Surgical Design, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 12, 1997
CIRCUMCISION TRAY, CAT. NO. 70340
K974286
Trinity Laboratories, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 06, 1997
MEDLINE CIRCUMCISION TRAY
K970282
Medline
Obstetrics & Gynecology · 41d
Cleared May 02, 1994
CIRCUMCISION TRAY
K935697
Cush Medical Products
Obstetrics & Gynecology · 153d
Cleared Feb 25, 1994
MOGAN CIRCUMCISION CLAMP
K926471
Thomasville Medical Assoc.
Obstetrics & Gynecology · 424d
Cleared Feb 25, 1994
GOMCO CIRCUMCISION CLAMP
K926535
Thomasville Medical Assoc.
Obstetrics & Gynecology · 422d
Cleared Feb 17, 1994
CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
K935491
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 94d
Cleared Aug 11, 1989
GOMCO CIRCUMCISION CLAMP
K894201
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 56d
Cleared Dec 08, 1988
BAXTER DISPOSABLE CIRCUMCISION TRAY
K884290
Baxter Healthcare Corp
Obstetrics & Gynecology · 57d

About Product Code HFX - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code HFX since 1988, with 27 receiving FDA clearance (average review time: 179 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - HFX Product Code

Recent submissions under HFX have taken an average of 268 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

HFX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →