The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Basket Graspers (urology).
| Device ID | K961611 |
| 510k Number | K961611 |
| Device Name: | OLYMPUS BASKET GRASPERS (UROLOGY) |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-25 |
| Decision Date | 1996-07-18 |
| Summary: | summary |