510(k) K152771

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long by Sumitomo Bakelite Co., Ltd. — Product Code KNS

K152771 is an FDA 510(k) premarket notification submitted by Sumitomo Bakelite Co., Ltd. for the device "SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long". The FDA issued a decision of Substantially Equivalent on Jun 17, 2016. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Sumitomo Bakelite Co., Ltd. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 17, 2016
Date Received
Sep 25, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type
510(k)