The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Captura Disposable Bronchoscope Biopsy Forceps.
Device ID | K163377 |
510k Number | K163377 |
Device Name: | Captura Disposable Bronchoscope Biopsy Forceps |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | Wilson-Cook Medical Inc. 4900 Bethania Station Road Winstom-salem, NC 27105 |
Contact | Ashley Howard |
Correspondent | Ashley Howard Wilson-Cook Medical Inc. 4900 Bethania Station Road Winstom-salem, NC 27105 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-01 |
Decision Date | 2018-02-21 |
Summary: | summary |