510(k) K101657

RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 by Boston Scientific Corp — Product Code KGE

K101657 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40". The FDA issued a decision of Substantially Equivalent on October 5, 2010. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2010
Date Received
June 11, 2010
Clearance Type
Abbreviated
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