The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Rigid Percutaneous Nephroscope.
| Device ID | K853486 |
| 510k Number | K853486 |
| Device Name: | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE |
| Classification | Kit, Nephroscope |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Scott J Solano |
| Correspondent | Scott J Solano OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FGA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761062555 | K853486 | 000 |
| 04042761051811 | K853486 | 000 |
| 04042761051866 | K853486 | 000 |
| 04042761023214 | K853486 | 000 |