The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Basket Graspers.
| Device ID | K955063 |
| 510k Number | K955063 |
| Device Name: | OLYMPUS BASKET GRASPERS |
| 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 | 1995-11-06 |
| Decision Date | 1996-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170244619 | K955063 | 000 |
| 14953170031998 | K955063 | 000 |
| 14953170031967 | K955063 | 000 |
| 14953170031912 | K955063 | 000 |
| 14953170031899 | K955063 | 000 |
| 14953170031868 | K955063 | 000 |
| 14953170031844 | K955063 | 000 |
| 14953170031813 | K955063 | 000 |
| 14953170031790 | K955063 | 000 |
| 14953170031776 | K955063 | 000 |
| 14953170032025 | K955063 | 000 |
| 14953170032056 | K955063 | 000 |
| 14953170244060 | K955063 | 000 |
| 14953170244053 | K955063 | 000 |
| 14953170244046 | K955063 | 000 |
| 14953170244039 | K955063 | 000 |
| 14953170160926 | K955063 | 000 |
| 14953170143202 | K955063 | 000 |
| 14953170143189 | K955063 | 000 |
| 14953170032476 | K955063 | 000 |
| 14953170032070 | K955063 | 000 |
| 14953170031752 | K955063 | 000 |