FDA Product Code
FDA Product Code FCL — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | Olympus Optical Co., Ltd. | 2003-07-16 | Traditional | PDF ↗ |
| K973611 | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS | Spectrascience, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K971315 | AUXILIARY INSTRUMENTS FOR URS | Richard Wolf Medical Instruments Corp. | 1997-09-15 | Traditional | PDF ↗ |
| K964120 | INJECTO FLUSH | Robert J. Jynch, Jr. | 1996-12-30 | Traditional | PDF ↗ |
| K963517 | SPECTRA SCIENCE BIOPSY FORCEPS | Spectrascience, Inc. | 1996-12-02 | Traditional | PDF ↗ |
| K955065 | OLYMPUS FB SERIES BIOPSY FORCEPS | Olympus America, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | Annex Medical, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K952391 | DYNABITE UROLOGICAL FORCEPS | Portlyn Corp. | 1995-06-01 | Traditional | PDF ↗ |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mill-Rose Laboratory | 1995-03-15 | Traditional | PDF ↗ |
| K946360 | MODULAR BIOPSY FORCEP | Cox Medical Ent., Inc. | 1995-03-06 | Traditional | PDF ↗ |
| K950559 | DIENER RETRIEVAL DEVICES | Mill-Rose Laboratory | 1995-02-16 | Traditional | PDF ↗ |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | Symbiosis Corp. | 1995-01-20 | Traditional | PDF ↗ |
| K944770 | LSVP INTERNATIONAL BIOPSY FORCEPS | Lsvp Intl., Inc. | 1994-10-13 | Traditional | PDF ↗ |
| K941816 | EMC FLEXIBLE BIOPSY FORCEPS | Enterprise Medical Corp. | 1994-07-13 | Traditional | PDF ↗ |
| K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS | Medi-Globe Corp. | 1994-07-12 | Traditional | PDF ↗ |
| K933135 | DAWN DISPOSABLE BIOPSY FORCEPS | Dawn Medical | 1994-03-07 | Traditional | PDF ↗ |
| K931957 | SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS | Symbiosis Corp. | 1994-02-28 | Traditional | PDF ↗ |
| K935070 | GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS | KARL STORZ Endoscopy-America, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K935250 | ACCU-PATH | Cox Medical Ent., Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K934186 | FORCEPS, BIOPSY, GASTROINTESTINAL | Primed Instruments, Inc. | 1993-12-14 | Traditional | PDF ↗ |
| K925392 | BIOPSY FORCEPS | Endo-Therapeutics, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K932265 | SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND | Symbiosis Corp. | 1993-08-09 | Traditional | PDF ↗ |
| K922396 | FUJINON FORCEPS -- MODIFICATION | Hobbs Medical, Inc. | 1992-12-10 | Traditional | PDF ↗ |
| K914497 | BIOPSY FORCEPS | Surgitek Medical Engineering Corp. | 1992-01-03 | Traditional | PDF ↗ |
| K914212 | BARD SINGULAR BIOPSY FORCEPS | C.R. Bard, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913883 | COX DISPOSABLE BIOPSY FORCEP | Cox Medical Ent., Inc. | 1991-10-05 | Traditional | PDF ↗ |
| K912549 | BARD(R) DISPOSABLE BIOPSY FORCEPS | C.R. Bard, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K912214 | BARD SINGULAR BIOPSY FORCEPS | C.R. Bard, Inc. | 1991-05-30 | Traditional | PDF ↗ |
| K896147 | BIOPSY FORCEP (NON-ELECTRIC) | Portlyn Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K893636 | GUARDIAN FORCEP | Endo-Scientific, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K900015 | NON-ELECTRIC BIOPSY FORCEPS | Esco Precision, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K900065 | NON-ELECTRIC BIOPSY FORCEPS | Esco Precision, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K892252 | BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-10-03 | Traditional | PDF ↗ |
| K873176 | HUFFMAN BIOPSY UNIT | Penn Medical Devices, Inc. | 1987-10-14 | Traditional | PDF ↗ |
| K871710 | BIOPSY FORCEPS | Frantz Medical Development, Ltd. | 1987-08-10 | Traditional | PDF ↗ |
| K844551 | HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT | Gobbs Medical, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K844690 | ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT | Jayco Pharmaceuticals | 1985-01-02 | Traditional | PDF ↗ |
| K840818 | BIOPSY FORCEPS | American Endoscopy, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K800963 | BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. | Mr Associates, Inc. | 1980-05-08 | Traditional | PDF ↗ |
Product code FCL · Class I · Gastroenterology, Urology. Data: openFDA.