Atlas FDA

HFB

22 FDA 510(k) clearances · Product code

96 daysmedian time to decision
527 days90th percentile
22clearances measured

FDA profile

Official device name
Forceps, Biopsy, Gynecological
Device class
Class I (low risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
1995: 1 · 1998: 2 · 1999: 1 · 2001: 2 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SPIRABRUSH CX BIOPSY INSTRUMENT (K011488)Trylon Corp.2002-02-22
CIT BIOPSY PUNCHES (K944444)Chirurgische Instrumente1995-09-29
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (K930773)Symbiosis Corp.1994-07-28
FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (K933767)Mahe-Medizintechnik1994-05-26
OWENS BIOPSY FORCEPS (K926595)Owens Industries, Inc.1994-05-25
ROTO FIT BIOPSY FORCEPS (K926527)Thomasville Medical Assoc.1994-02-25
THOMAS MEDICAL BIOPSY FORCEPS (K930036)Thomasville Medical Assoc.1994-02-24
TISCHLER BIOPSY FORCEPS (K926538)Thomasville Medical Assoc.1994-02-24
OWENS BIOPSY FORCEPS (K924224)Owens Precision Systems, Inc.1994-02-04
CROAK OVARIAN BIOPSY FORCEP (K902049)Gynescope Corp.1990-06-07
EVER-SHARP BIOPSY FORCEPS (K895303)Southwest Medical Mfg., Inc.1990-01-16
ROTO FIT BIOPSY FORCEPS (K891043)Zinnanti Surgical Instruments, Inc.1989-03-22
TISCHLER BIOPSY FORCEPS (K891034)Zinnanti Surgical Instruments, Inc.1989-03-17
ZSI BIOPSY FORCEPS (K891027)Zinnanti Surgical Instruments, Inc.1989-03-17
CERVICAL BIOPSY FORCEPS (K890380)Kinetic Medical Products1989-02-27
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (K852357)Gyneco, Inc.1985-07-05
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. (K851110)The Huxley Instrument Corp.1985-04-08
TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (K842112)J. Sklar Mfg. Co., Inc.1984-07-03
CIN-SHEAR (K840352)Roland J. Zwick, Inc.1984-04-05
BIOPSER (K820519)Advanced Biomedical Instruments1982-04-29
KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 (K802458)J. Sklar Mfg. Co., Inc.1981-01-12
KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 (K802457)J. Sklar Mfg. Co., Inc.1981-01-12

Track HFB automatically

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