MODULAR BIOPSY FORCEP
FDA 510(k) clearance K946360 · decided 1995-03-06
Clearance details
- K-number
- K946360
- Device name
- MODULAR BIOPSY FORCEP
- Applicant
- Cox Medical Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-30
- Decision date
- 1995-03-06
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- FCL
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ventura, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 Laboratory | 1995-03-15 |
| DIENER RETRIEVAL DEVICES (K950559) | Mill-Rose Laboratory | 1995-02-16 |
| SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS (K946238) | Symbiosis Corp. | 1995-01-20 |
| LSVP INTERNATIONAL BIOPSY FORCEPS (K944770) | Lsvp Intl., Inc. | 1994-10-13 |
Recalls involving this device
No recalls on record reference this clearance.