Accu-Path
FDA 510(k) K935250 · Cox Medical Ent., Inc.
510(k) numberK935250
Submission
- Device name
- Accu-Path
- Applicant
- Cox Medical Ent., Inc.
Ventura, CA, US - Received
- November 1, 1993
- Decision date
- January 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K950689 | UcbMNL · Traditional | 03/06/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | 03/06/1995SE |
| K941464 | Basics Endoscopy SystemOCZ · Traditional | 08/05/1994SE |
| K940911 | Basics Endoscopy SystemKGE · Traditional | 05/16/1994SE |
| K932790 | Thermal OptionKGE · Traditional | 01/28/1994SE |
| K924655 | Cox Disposable Endoscope Cleaning BRUSH(CB-X2)FEB · Traditional | 12/15/1992SE |
| K923671 | Cox Disposable Polypectomy SnaresFDI · Traditional | 10/13/1992SE |
| K923672 | Cox Disposable Endoscope Cleaning BrushFEB · Traditional | 09/23/1992SE |
| K923489 | Cox Disposable Retrieval DevicesOCZ · Traditional | 09/23/1992SE |
| K914466 | Cox Disposable Cytology BrushesFDX · Traditional | 10/25/1991SE |
Questions and answers
When was Accu-Path cleared by the FDA?
Accu-Path (K935250) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 81 days after the submission was received.
What is the product code of K935250?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.