The following data is part of a premarket notification filed by Olympus Medical Systems Copr. with the FDA for Single Use Preloaded Sphincterotome V (distal Wireguided); Single Use Sp.
| Device ID | K141991 |
| 510k Number | K141991 |
| Device Name: | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS COPR. 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole OLYMPUS MEDICAL SYSTEMS COPR. 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-22 |
| Decision Date | 2015-03-31 |
| Summary: | summary |