The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Zimmon Needle Knife Papillotome.
| Device ID | K171993 |
| 510k Number | K171993 |
| Device Name: | Zimmon Needle Knife Papillotome |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Doris A. Hawks |
| Correspondent | Doris A. Hawks Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002227170 | K171993 | 000 |
| 00827002218222 | K171993 | 000 |