Olympus FB Series Biopsy Forceps
FDA 510(k) K955065 · Olympus America, Inc.
510(k) numberK955065
Submission
- Device name
- Olympus FB Series Biopsy Forceps
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- November 6, 1995
- Decision date
- January 24, 1996
- 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 |
| 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 |
| K950559 | Diener Retrieval DevicesFCL · Traditional | Mill-Rose Laboratory | 02/16/1995SE |
More from Mill-Rose Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K111788 | Endoeye HD IIHET · Traditional | 01/13/2012SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | 03/18/2009SE |
| K073490 | Olympus Igg ReagentCFN · Traditional | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | 02/11/2008SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | 04/06/2007SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | 03/23/2007SE |
| K061499 | OsferionMQV · Traditional | 01/26/2007SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
| K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117CJY · Traditional | 10/05/2006SE |
Questions and answers
When was Olympus FB Series Biopsy Forceps cleared by the FDA?
Olympus FB Series Biopsy Forceps (K955065) received a 510(k) decision of Substantially Equivalent on January 24, 1996, 79 days after the submission was received.
What is the product code of K955065?
The FDA product code is FCL – Forceps, Biopsy, Non-Electric, a Class I (low risk) device regulated under 21 CFR 876.1075.