Panels › Gastroenterology, Urology › Product code FCL · Class 1
Forceps, Biopsy, Non-Electric
Regulation 876.1075
0510(k)s in 12 months (39 all time)
3recalls in 12 months (11 all time)
2recalls that name a 510(k)
Top companies in FCL
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 6 |
| Richard Wolf GmbH | 0 | 4 |
| C.R. Bard, Inc. | 3 | 0 |
| Cox Medical Ent., Inc. | 3 | 0 |
| Symbiosis Corp. | 3 | 0 |
| Esco Precision, Inc. | 2 | 0 |
| Mill-Rose Laboratory | 2 | 0 |
| Portlyn Corp. | 2 | 0 |
| Spectrascience, Inc. | 2 | 0 |
| American Endoscopy, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2003 | K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE Olympus Optical Co., Ltd., JP | FCL |
| Dec 2, 1997 | K973611 | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS Spectrascience, Inc. | FCL |
| Sep 15, 1997 | K971315 | AUXILIARY INSTRUMENTS FOR URS Richard Wolf Medical Instruments Corp. | FCL |
| Dec 30, 1996 | K964120 | INJECTO FLUSH Robert J. Jynch, Jr. | FCL |
| Dec 2, 1996 | K963517 | SPECTRA SCIENCE BIOPSY FORCEPS Spectrascience, Inc. | FCL |
| Jan 24, 1996 | K955065 | OLYMPUS FB SERIES BIOPSY FORCEPS Olympus America, Inc. | FCL |
| Jul 19, 1995 | K952863 | FORCEPS, BIOPSY, NON-ELECTRIC Annex Medical, Inc. | FCL |
| Jun 1, 1995 | K952391 | DYNABITE UROLOGICAL FORCEPS Portlyn Corp. | FCL |
| Mar 15, 1995 | K951048 | RITE-BITE BIOPSY FORCEPS Mill-Rose Laboratory | FCL |
| Mar 6, 1995 | K946360 | MODULAR BIOPSY FORCEP Cox Medical Ent., Inc. | FCL |
| Feb 16, 1995 | K950559 | DIENER RETRIEVAL DEVICES Mill-Rose Laboratory | FCL |
| Jan 20, 1995 | K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS Symbiosis Corp. | FCL |
| Oct 13, 1994 | K944770 | LSVP INTERNATIONAL BIOPSY FORCEPS Lsvp Intl., Inc. | FCL |
| Jul 13, 1994 | K941816 | EMC FLEXIBLE BIOPSY FORCEPS Enterprise Medical Corp. | FCL |
| Jul 12, 1994 | K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS Medi-Globe Corp. | FCL |
| Mar 7, 1994 | K933135 | DAWN DISPOSABLE BIOPSY FORCEPS Dawn Medical | FCL |
| Feb 28, 1994 | K931957 | SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS Symbiosis Corp. | FCL |
| Jan 25, 1994 | K935070 | GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS KARL STORZ Endoscopy-America, Inc. | FCL |
| Jan 21, 1994 | K935250 | ACCU-PATH Cox Medical Ent., Inc. | FCL |
| Dec 14, 1993 | K934186 | FORCEPS, BIOPSY, GASTROINTESTINAL Primed Instruments, Inc., CA | FCL |
| Nov 5, 1993 | K925392 | BIOPSY FORCEPS Endo-Therapeutics, Inc. | FCL |
| Aug 9, 1993 | K932265 | SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND Symbiosis Corp. | FCL |
| Dec 10, 1992 | K922396 | FUJINON FORCEPS -- MODIFICATION Hobbs Medical, Inc. | FCL |
| Jan 3, 1992 | K914497 | BIOPSY FORCEPS Surgitek Medical Engineering Corp. | FCL |
| Nov 27, 1991 | K914212 | BARD SINGULAR BIOPSY FORCEPS C.R. Bard, Inc. | FCL |
| Oct 5, 1991 | K913883 | COX DISPOSABLE BIOPSY FORCEP Cox Medical Ent., Inc. | FCL |
| Sep 10, 1991 | K912549 | BARD(R) DISPOSABLE BIOPSY FORCEPS C.R. Bard, Inc. | FCL |
| May 30, 1991 | K912214 | BARD SINGULAR BIOPSY FORCEPS C.R. Bard, Inc. | FCL |
| Apr 16, 1990 | K896147 | BIOPSY FORCEP (NON-ELECTRIC) Portlyn Corp. | FCL |
| Apr 9, 1990 | K893636 | GUARDIAN FORCEP Endo-Scientific, Inc. | FCL |
| Mar 15, 1990 | K900065 | NON-ELECTRIC BIOPSY FORCEPS Esco Precision, Inc. | FCL |
| Mar 15, 1990 | K900015 | NON-ELECTRIC BIOPSY FORCEPS Esco Precision, Inc. | FCL |
| Oct 3, 1989 | K892252 | BIOPSY FORCEPS Zinnanti Surgical Instruments, Inc. | FCL |
| Oct 14, 1987 | K873176 | HUFFMAN BIOPSY UNIT Penn Medical Devices, Inc. | FCL |
| Aug 10, 1987 | K871710 | BIOPSY FORCEPS Frantz Medical Development, Ltd. | FCL |
| Jan 3, 1985 | K844551 | HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT Gobbs Medical, Inc. | FCL |
| Jan 2, 1985 | K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT Jayco Pharmaceuticals | FCL |
| Apr 13, 1984 | K840818 | BIOPSY FORCEPS American Endoscopy, Inc. | FCL |
| May 8, 1980 | K800963 | BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. Mr Associates, Inc. | FCL |
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