510(k) K171973

Captura® Disposable Hot Biopsy Forceps by Wilson-Cook Medical, Inc. — Product Code KGE

K171973 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Captura® Disposable Hot Biopsy Forceps". The FDA issued a decision of Substantially Equivalent on March 21, 2018. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2018
Date Received
June 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type