Non-Electric Biopsy Forceps
FDA 510(k) K900065 · Esco Precision, Inc.
510(k) numberK900065
Submission
- Device name
- Non-Electric Biopsy Forceps
- Applicant
- Esco Precision, Inc.
Stony Brook, NY, US - Received
- January 4, 1990
- Decision date
- March 15, 1990
- 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.
Questions and answers
When was Non-Electric Biopsy Forceps cleared by the FDA?
Non-Electric Biopsy Forceps (K900065) received a 510(k) decision of Substantially Equivalent on March 15, 1990, 70 days after the submission was received.
What is the product code of K900065?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.