FDA 510(k)

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

K-Number: K190621 · 2019-04-23

Decision Date2019-04-23

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K190621. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K190621.

When did SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long receive FDA 510(k) clearance?

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long received FDA 510(k) clearance on 2019-04-23, under 510(k) number K190621.

Who is the listed applicant for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

The FDA 510(k) record lists Sumitomo Bakelite Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

The FDA product code for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is KNS.

Other records listing Sumitomo Bakelite Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182520Flexible Overtube K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut type K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long

Related Devices (Code: KNS)

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.