Atlas FDA

HCZ

24 FDA 510(k) clearances · Product code

72 daysmedian time to decision
422 days90th percentile
24clearances measured

FDA profile

Official device name
Forceps, Surgical, Gynecological
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 1 · 2003: 3 · 2005: 2 · 2006: 2 · 2008: 3 · 2014: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Fetzer Medical Gynecological Forceps (K172661)Fetzer Medical GmbH & Co. KG2018-05-08
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS (K134047)Integra LifeSciences Corporation2014-04-11
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (K092840)Instrumed International, Inc.2009-12-03
FORCEPS, SURGICAL GYNECOLOGICAL (K944055)Owens Precision Systems, Inc.1994-09-20
PEARL PACKING FORCEPS (K941528)Cook Urological, Inc.1994-05-12
CORSON MYOMA GRASPING FORCEPS (K926484)Thomasville Medical Assoc.1994-02-25
Z-CLAMP FORCEPS (K926533)Thomasville Medical Assoc.1994-02-25
HYSTERECTOMY FORCEPS (K926531)Thomasville Medical Assoc.1994-02-25
VARIOUS FORCEPS (K930799)Thomasville Medical Assoc.1994-02-24
OVUM FORCEPS (K926528)Thomasville Medical Assoc.1994-02-24
FORCEPS: MCGRAVEY, MCINDOE, GILLIS (K930039)Thomasville Medical Assoc.1994-02-24
LAPAROSCOPIC FORCEPS (K911474)United States Endoscopy Group, Inc.1991-07-03
DEFLECTING WIRE GRASPER (K903707)Cook, Inc.1990-09-26
ZEPPELIN FORCEPS (K901897)Kirwan Surgical Products, Inc.1990-06-29
FORCEPS, SURGICAL, GYNECOLOGICAL (K892820)The South India Surgical Co. Pvt. , Ltd.1989-06-22
HYSTERECTOMY FORCEPS - (SEVERAL MODELS) (K891036)Zinnanti Surgical Instruments, Inc.1989-03-17
ZEPPELIN FORCEPS (K891047)Zinnanti Surgical Instruments, Inc.1989-03-17
HYSTERECTOMY FORCEPS (K890383)Kinetic Medical Products1989-02-16
PLACENTA AND OVUM FORCEPS (K890386)Kinetic Medical Products1989-02-13
UTERINE DRESSING FORCEPS (K890378)Kinetic Medical Products1989-02-13
BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 (K852721)The Huxley Instrument Corp.1985-09-06
OP-CON SURGICAL INSTRUMENTS #4 (K834174)Imm Enterprises , Ltd.1983-12-27
VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) (K810391)Edward Weck, Inc.1981-03-04
MINICLAMPS, STABILIZ., FALLOPIAN TUBE (K772229)J. Sklar Mfg. Co., Inc.1978-01-03

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Every clearance here is in the API, with alerts when new ones post.