Captura® Disposable Hot Biopsy Forceps

Forceps, Biopsy, Electric

Wilson-Cook Medical, Inc.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Captura® Disposable Hot Biopsy Forceps.

Pre-market Notification Details

• Device ID: K171973
• 510k Number: K171973
• Device Name: Captura® Disposable Hot Biopsy Forceps
• Classification: Forceps, Biopsy, Electric
• Applicant: Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105
• Contact: Ashley Howard
• Correspondent: Ashley Howard; Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105
• Product Code: KGE
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-30
• Decision Date: 2018-03-21
• Summary: summary