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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

ApplicantSumitomo Bakelite Co., Ltd.
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 a medical device manufactured by Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2019-04-23 under approval 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. It is manufactured by Sumitomo Bakelite Co., Ltd.. The 510(k) number is K190621.

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

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 approval number K190621.

What company makes 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 manufactured by Sumitomo Bakelite Co., Ltd..

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.

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Other Devices by Sumitomo Bakelite Co., Ltd.

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

Related Devices (Code: KNS)

K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. K160417Rezum SystemNxthera, Inc. K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp. K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.

Official Source

View on FDA Database →

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

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