The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Endoeye Flex Deflectable Videoscope Olympus Ltf-s190-5.
| Device ID | K201832 |
| 510k Number | K201832 |
| Device Name: | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Jon Gilbert Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2021-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170310355 | K201832 | 000 |
| 04953170452031 | K201832 | 000 |
| 04953170316159 | K201832 | 000 |
| 04953170434648 | K201832 | 000 |