FCL · Forceps, Biopsy, Non-Electric
Gastroenterology, Urology · 21 CFR 876.1075 · Class 1
Overview
| Product Code | FCL |
|---|---|
| Device Name | Forceps, Biopsy, Non-Electric |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032092 | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE | Olympus Optical Co., Ltd. | Jul 16, 2003 | SESE |
| K973611 | SPECTRASCIENCE REUSABLE BIOPSY FORCEPS | Spectrascience, Inc. | Dec 2, 1997 | SESE |
| K971315 | AUXILIARY INSTRUMENTS FOR URS | Richard Wolf Medical Instruments Corp. | Sep 15, 1997 | SESE |
| K964120 | INJECTO FLUSH | Robert J. Jynch, Jr. | Dec 30, 1996 | SESE |
| K963517 | SPECTRA SCIENCE BIOPSY FORCEPS | Spectrascience, Inc. | Dec 2, 1996 | SESE |
| K955065 | OLYMPUS FB SERIES BIOPSY FORCEPS | Olympus America, Inc. | Jan 24, 1996 | SESE |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | Annex Medical, Inc. | Jul 19, 1995 | SESE |
| K952391 | DYNABITE UROLOGICAL FORCEPS | Portlyn Corp. | Jun 1, 1995 | SESE |
| K951048 | RITE-BITE BIOPSY FORCEPS | Mill-Rose Laboratory | Mar 15, 1995 | SESE |
| K946360 | MODULAR BIOPSY FORCEP | Cox Medical Ent., Inc. | Mar 6, 1995 | SESE |
| K950559 | DIENER RETRIEVAL DEVICES | Mill-Rose Laboratory | Feb 16, 1995 | SESE |
| K946238 | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS | Symbiosis Corp. | Jan 20, 1995 | SESE |
| K944770 | LSVP INTERNATIONAL BIOPSY FORCEPS | Lsvp Intl., Inc. | Oct 13, 1994 | SESE |
| K941816 | EMC FLEXIBLE BIOPSY FORCEPS | Enterprise Medical Corp. | Jul 13, 1994 | SESE |
| K941359 | GIP/MEDI-GLOBE BIOPSY FORCEPS | Medi-Globe Corp. | Jul 12, 1994 | SESE |
| K933135 | DAWN DISPOSABLE BIOPSY FORCEPS | Dawn Medical | Mar 7, 1994 | SESE |
| K931957 | SYMBIOSIS DISPOSABLE UROLOGICAL BIOPSY FORCEPS | Symbiosis Corp. | Feb 28, 1994 | SESE |
| K935070 | GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS | KARL STORZ Endoscopy-America, Inc. | Jan 25, 1994 | SESE |
| K935250 | ACCU-PATH | Cox Medical Ent., Inc. | Jan 21, 1994 | SESE |
| K934186 | FORCEPS, BIOPSY, GASTROINTESTINAL | Primed Instruments, Inc. | Dec 14, 1993 | SESE |
Top Applicants
- C.R. Bard, Inc. — 3 clearances
- Cox Medical Ent., Inc. — 3 clearances
- Symbiosis Corp. — 3 clearances
- Esco Precision, Inc. — 2 clearances
- Mill-Rose Laboratory — 2 clearances
