The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Sphincterotome V (distal Wireguided) Kd-vc412q-0215.
| Device ID | K160241 |
| 510k Number | K160241 |
| Device Name: | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| 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 | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170399456 | K160241 | 000 |
| 14953170371155 | K160241 | 000 |