Symbiosis Gastrointestinal Biopsy Forceps
FDA 510(k) K946238 · Symbiosis Corp.
510(k) numberK946238
Submission
- Device name
- Symbiosis Gastrointestinal Biopsy Forceps
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- December 22, 1994
- Decision date
- January 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K955119 | Symbiosis Monopolar Electrosurgical Roller ElectrodesHIH · Traditional | 01/18/1996SE |
| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | 01/17/1996SE |
| K953242 | Symbiosis Monoplar Electrosurgical ElectrodesKNF · Traditional | 10/06/1995SE |
| K952432 | Symbiosis Bipolar ForcepsGEI · Traditional | 07/05/1995SE |
| K951387 | Symbiosis Bipolar ScissorsGCJ · Traditional | 04/10/1995SE |
| K950286 | Symbiosis Bipolar ScissorsGCJ · Traditional | 02/03/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | 07/28/1994SE |
| K941426 | Symbiosis Reusable Monopolar Electrosurgical ProbeGEI · Traditional | 06/22/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | 03/15/1994SE |
| K931957 | Symbiosis Disposable Urological Biopsy ForcepsFCL · Traditional | 02/28/1994SE |
Questions and answers
When was Symbiosis Gastrointestinal Biopsy Forceps cleared by the FDA?
Symbiosis Gastrointestinal Biopsy Forceps (K946238) received a 510(k) decision of Substantially Equivalent on January 20, 1995, 29 days after the submission was received.
What is the product code of K946238?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.