Biopsy Forceps
FDA 510(k) K871710 · Frantz Medical Development, Ltd.
510(k) numberK871710
Submission
- Device name
- Biopsy Forceps
- Applicant
- Frantz Medical Development, Ltd.
New York, NY, US - Received
- May 1, 1987
- Decision date
- August 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCL – Forceps, Biopsy, Non-Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | Olympus Optical Co., Ltd. | 07/16/2003SE |
| K973611 | Spectrascience Reusable Biopsy ForcepsFCL · Traditional | Spectrascience, Inc. | 12/02/1997SE |
| K971315 | Auxiliary Instruments for UrsFCL · Traditional | Richard Wolf Medical Instruments Corp. | 09/15/1997SE |
| K964120 | Injecto FlushFCL · Traditional | Robert J. Jynch, Jr. | 12/30/1996SE |
| K963517 | Spectra Science Biopsy ForcepsFCL · Traditional | Spectrascience, Inc. | 12/02/1996SE |
| K955065 | Olympus FB Series Biopsy ForcepsFCL · Traditional | Olympus America, Inc. | 01/24/1996SE |
| K952863 | Forceps, Biopsy, Non-ElectricFCL · Traditional | Annex Medical, Inc. | 07/19/1995SE |
| K952391 | Dynabite Urological ForcepsFCL · Traditional | Portlyn Corp. | 06/01/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | Mill-Rose Laboratory | 03/15/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | Cox Medical Ent., Inc. | 03/06/1995SE |
More from Cox Medical Ent., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981541 | Clearstar Enteral Nutrition PumpLZH · Traditional | 08/13/1998SE |
| K905282 | Endoscopic Accessory to the Light SourceGCT · Traditional | 03/19/1991SEKD |
| K873119 | Flexiflo Companion Enteral Nutrition PumpLZH · Traditional | 11/05/1987SE |
| K863508 | Frantz Medical ElectrodeDXR · Traditional | 02/06/1987SE |
Questions and answers
When was Biopsy Forceps cleared by the FDA?
Biopsy Forceps (K871710) received a 510(k) decision of Substantially Equivalent on August 10, 1987, 101 days after the submission was received.
What is the product code of K871710?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.