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

FDA 510(k) K152771 · Sumitomo Bakelite Co., Ltd.

Substantially Equivalent

510(k) numberK152771

Submission

Device name
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
Applicant
Sumitomo Bakelite Co., Ltd.
Tokyo, JP
Received
September 25, 2015
Decision date
June 17, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

Other 510(k)s with product code KNS

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K262460Rezum SystemKNS · Traditional Boston Scientific09/03/2026SE
K260962SphincterotomeKNS · Traditional Taewoong Medical Co., Ltd.05/21/2026SE
K252388Vanquish Water Vapor Ablation DeviceKNS · Traditional Francis Medical, Inc.11/26/2025SE
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional Olympus Medical Systems Corporation11/25/2025SE
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional Olympus Medical Systems Corp.10/17/2025SE
K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional Olympus Medical Systems Corporation10/10/2025SE
K251104SureTome™ SW Sphincterotome with DomeTipKNS · Traditional Wilson-Cook Medical09/29/2025SE
K251226Aqua Medical RF Vapor Ablation SystemKNS · Traditional Aqua Medical, Inc.08/08/2025SE
K250584Rezum SystemKNS · Traditional Boston Scientific Corporation06/11/2025SE
K242774SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional Creo Medical, Ltd.06/06/2025SE

More from Creo Medical, Ltd.

510(k)DeviceDecision
K182520Flexible OvertubeFED · Traditional 05/15/2019SE
K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongKNS · Traditional 04/23/2019SE
K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeFDS · Traditional 05/08/2018SE

Questions and answers

When was SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long cleared by the FDA?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long (K152771) received a 510(k) decision of Substantially Equivalent on June 17, 2016, 266 days after the submission was received.

What is the product code of K152771?

The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.