The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Aspiration Needle Na-u201h.
| Device ID | K181994 |
| 510k Number | K181994 |
| Device Name: | Single Use Aspiration Needle NA-U201H |
| Classification | Biopsy Needle |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2018-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170402644 | K181994 | 000 |
| 14953170402620 | K181994 | 000 |
| 14953170402606 | K181994 | 000 |
| 14953170402583 | K181994 | 000 |
| 14953170402569 | K181994 | 000 |
| 14953170402545 | K181994 | 000 |