The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Guide Sheath Kit-401, K-402.
| Device ID | K212667 |
| 510k Number | K212667 |
| Device Name: | Single Use Guide Sheath Kit-401, K-402 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Teffany Hutto Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2021-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170408981 | K212667 | 000 |
| 14953170409018 | K212667 | 000 |
| 14953170401968 | K212667 | 000 |