K032092 is an FDA 510(k) clearance for the OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE. This device is classified as a Forceps, Biopsy, Non-electric (Class I - General Controls, product code FCL).
Submitted by Olympus Optical Co., Ltd. (Nishitama-Gun Tokyo, JP). The FDA issued a Cleared decision on July 16, 2003, 9 days after receiving the submission on July 7, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K032092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2003 |
| Decision Date | July 16, 2003 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1075 |