The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Xcyf-tp3 Cystofiberscope/nephrofiberscope.
| Device ID | K032092 |
| 510k Number | K032092 |
| Device Name: | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | OLYMPUS OPTICAL CO., LTD. 34-3 HIRAI HINODE-MACHI, Nishitima-gun, Tokyo, JP 190-0182 |
| Contact | Masao Wada |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FCL |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FDI |
| Subsequent Product Code | FGA |
| Subsequent Product Code | KGE |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339424 | K032092 | 000 |
| 04953170339417 | K032092 | 000 |
| 04953170328817 | K032092 | 000 |
| 04953170292521 | K032092 | 000 |
| 04953170292323 | K032092 | 000 |
| 04953170286964 | K032092 | 000 |
| 04953170411182 | K032092 | 000 |
| 04953170411144 | K032092 | 000 |