Atlas FDA

FCL

39 FDA 510(k) clearances · Product code

76 daysmedian time to decision
252 days90th percentile
39clearances measured

FDA profile

Official device name
Forceps, Biopsy, Non-Electric
Device class
Class I (low risk)
Regulation
21 CFR 876.1075
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 30 · 2022: 70 · 2023: 68 · 2024: 60 · 2025: 56 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (K032092)Olympus Optical Co., Ltd.2003-07-16
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (K973611)Spectrascience, Inc.1997-12-02
AUXILIARY INSTRUMENTS FOR URS (K971315)Richard Wolf Medical Instruments Corp.1997-09-15
INJECTO FLUSH (K964120)Robert J. Jynch, Jr.1996-12-30
SPECTRA SCIENCE BIOPSY FORCEPS (K963517)Spectrascience, Inc.1996-12-02
OLYMPUS FB SERIES BIOPSY FORCEPS (K955065)Olympus America, Inc.1996-01-24
FORCEPS, BIOPSY, NON-ELECTRIC (K952863)Annex Medical, Inc.1995-07-19
DYNABITE UROLOGICAL FORCEPS (K952391)Portlyn Corp.1995-06-01
RITE-BITE BIOPSY FORCEPS (K951048)Mill-Rose Laboratory1995-03-15
MODULAR BIOPSY FORCEP (K946360)Cox Medical Ent., Inc.1995-03-06
DIENER RETRIEVAL DEVICES (K950559)Mill-Rose Laboratory1995-02-16
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (K946238)Symbiosis Corp.1995-01-20
LSVP INTERNATIONAL BIOPSY FORCEPS (K944770)Lsvp Intl., Inc.1994-10-13
EMC FLEXIBLE BIOPSY FORCEPS (K941816)Enterprise Medical Corp.1994-07-13
GIP/MEDI-GLOBE BIOPSY FORCEPS (K941359)Medi-Globe Corp.1994-07-12
DAWN DISPOSABLE BIOPSY FORCEPS (K933135)Dawn Medical1994-03-07
SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS (K931957)Symbiosis Corp.1994-02-28
GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS (K935070)KARL STORZ Endoscopy-America, Inc.1994-01-25
ACCU-PATH (K935250)Cox Medical Ent., Inc.1994-01-21
FORCEPS, BIOPSY, GASTROINTESTINAL (K934186)Primed Instruments, Inc.1993-12-14
BIOPSY FORCEPS (K925392)Endo-Therapeutics, Inc.1993-11-05
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND (K932265)Symbiosis Corp.1993-08-09
FUJINON FORCEPS -- MODIFICATION (K922396)Hobbs Medical, Inc.1992-12-10
BIOPSY FORCEPS (K914497)Surgitek Medical Engineering Corp.1992-01-03
BARD SINGULAR BIOPSY FORCEPS (K914212)C.R. Bard, Inc.1991-11-27
COX DISPOSABLE BIOPSY FORCEP (K913883)Cox Medical Ent., Inc.1991-10-05
BARD(R) DISPOSABLE BIOPSY FORCEPS (K912549)C.R. Bard, Inc.1991-09-10
BARD SINGULAR BIOPSY FORCEPS (K912214)C.R. Bard, Inc.1991-05-30
BIOPSY FORCEP (NON-ELECTRIC) (K896147)Portlyn Corp.1990-04-16
GUARDIAN FORCEP (K893636)Endo-Scientific, Inc.1990-04-09
NON-ELECTRIC BIOPSY FORCEPS (K900065)Esco Precision, Inc.1990-03-15
NON-ELECTRIC BIOPSY FORCEPS (K900015)Esco Precision, Inc.1990-03-15
BIOPSY FORCEPS (K892252)Zinnanti Surgical Instruments, Inc.1989-10-03
HUFFMAN BIOPSY UNIT (K873176)Penn Medical Devices, Inc.1987-10-14
BIOPSY FORCEPS (K871710)Frantz Medical Development, Ltd.1987-08-10
HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT (K844551)Gobbs Medical, Inc.1985-01-03
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (K844690)Jayco Pharmaceuticals1985-01-02
BIOPSY FORCEPS (K840818)American Endoscopy, Inc.1984-04-13
BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. (K800963)Mr Associates, Inc.1980-05-08

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