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-4025/na-u401sx-4025n.
| Device ID | K180668 |
| 510k Number | K180668 |
| Device Name: | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N |
| 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 | 2018-03-14 |
| Decision Date | 2018-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170402002 | K180668 | 000 |