The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Aspiration Needle Na-u401sx.
| Device ID | K160098 |
| 510k Number | K160098 |
| Device Name: | Single Use Aspiration Needle NA-U401SX |
| Classification | Biopsy Needle |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L. Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170388320 | K160098 | 000 |
| 14953170388283 | K160098 | 000 |
| 14953170388245 | K160098 | 000 |