The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Aspiration Needle.
| Device ID | K190239 |
| 510k Number | K190239 |
| Device Name: | Single Use Aspiration Needle |
| Classification | Bronchoscope Accessory |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Daphney Germain-kolawole Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170402019 | K190239 | 000 |
| 14953170402002 | K190239 | 000 |