The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Acusnare Polypectomy Snare.
Device ID | K173673 |
510k Number | K173673 |
Device Name: | AcuSnare Polypectomy Snare |
Classification | Snare, Flexible |
Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Contact | Theresa De Prat |
Correspondent | Theresa De Prat Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-30 |
Decision Date | 2018-08-24 |
Summary: | summary |