Atlas FDA

HFX

27 FDA 510(k) clearances · Product code

100 daysmedian time to decision
424 days90th percentile
27clearances measured

FDA profile

Official device name
Clamp, Circumcision
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 13 · 2020: 22 · 2023: 33 · 2024: 121 · 2025: 122 · 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Konig Bell Circumcision Clamp (K251687)Medline Industries, LP2026-02-25
Wee Bell (K221356)Wee Medical2023-02-02
Konig Mogen Clamp (K212911)Medline Industries, Inc.2022-11-18
Circumplast Circumcision Device (K151095)Novadien Healthcare2015-09-18
MALE CIRCUMCISION KITS:RAPIDECLAMP (K142163)Medicfit Technology Sdn Bhd2015-04-20
SHANGRING (K131373)Wuhu Snnda Medical Treatment Appliance Technology2013-06-25
SHANGRING (K121789)Wuhu Snna Medical Treatment Appliance Technology C2012-08-03
PREPEX SYSTEM (K103695)Circ Medtech2012-01-10
MEDICON MOGEN CLAMP (K100916)Medicon EG2010-12-06
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (K061539)Clinical Innovations, LLC2007-09-20
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (K063429)Generic Medical Device, Inc.2007-01-17
SURGICAL DESIGN CIRCUMCISION CLAMP (K043533)Surgical Design, Inc.2005-04-01
FINE SURGICAL CIRCUMCISION CLAMP (K040052)Fine Surgical Instrument Corp.2004-04-09
SMART KLAMP VARIOUS BY SIZE (K032091)Emergogroup, Inc.2004-03-08
T.S. MEDICAL CIRCUMCISION CLAMP (K033403)T.S. Medical2004-01-22
KILEJIAN CIRCUMCISOR (K010867)Iris Surgical, LLC2001-05-03
CIRCUMCISION TRAY, CAT. NO. 70340 (K974286)Trinity Laboratories, Inc.1997-12-12
MEDLINE CIRCUMCISION TRAY (K970282)Medline1997-03-06
KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] (K945949)Vlm Surgical, Inc.1995-07-25
CIRCUMCISION TRAY (K935697)Cush Medical Products1994-05-02
MOGAN CIRCUMCISION CLAMP (K926471)Thomasville Medical Assoc.1994-02-25
GOMCO CIRCUMCISION CLAMP (K926535)Thomasville Medical Assoc.1994-02-25
CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) (K935491)Tri-State Hospital Supply Corp.1994-02-17
ONE/CIRC (CIRCUMCISION CLAMP) (K900370)Bionix Development Corp.1990-04-16
GOMCO CIRCUMCISION CLAMP (K894201)Zinnanti Surgical Instruments, Inc.1989-08-11
CENTURION CIRCLAMP (K890897)Tri-State Hospital Supply Corp.1989-03-28
BAXTER DISPOSABLE CIRCUMCISION TRAY (K884290)Baxter Healthcare Corp1988-12-08

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