The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Ultrathin Ureteroscopes.
| Device ID | K951855 |
| 510k Number | K951855 |
| Device Name: | ULTRATHIN URETEROSCOPES |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-21 |
| Decision Date | 1995-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761063043 | K951855 | 000 |
| 04042761034890 | K951855 | 000 |
| 04042761063012 | K951855 | 000 |
| 04042761063029 | K951855 | 000 |
| 04042761029537 | K951855 | 000 |
| 04042761029544 | K951855 | 000 |
| 04042761029940 | K951855 | 000 |
| 04042761062497 | K951855 | 000 |
| 04042761062503 | K951855 | 000 |
| 04042761062510 | K951855 | 000 |
| 04042761063036 | K951855 | 000 |
| 04042761034883 | K951855 | 000 |