SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

SUMITOMO BAKELITE CO., LTD.

The following data is part of a premarket notification filed by Sumitomo Bakelite Co., Ltd. with the FDA for Sb Knife Jr Type, Sb Knife Short Type, Sb Knife Standard Type, Sb Knife Jr Type - Long.

Pre-market Notification Details

• Device ID: K152771
• 510k Number: K152771
• Device Name: SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long
• Classification: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Applicant: SUMITOMO BAKELITE CO., LTD. 5-8, HIGASHI-SHINAGAWA 2- CHOME, SHINAGAWA-KU, Tokyo, JP 140-0002
• Contact: Shiro Agehama
• Correspondent: Michael Beeltje; VAUPELL CORP. 101 HP ALMGREN DR. Agawam, MA 01001
• Product Code: KNS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-25
• Decision Date: 2016-06-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24545499064695	K152771	000
24545499064688	K152771	000
24545499064671	K152771	000
24545499064664	K152771	000