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FDA 510(k)

SB Knife Jr2 (MD-47702 and MD-47702L)

K-Number: K241855 · 2025-03-26

ApplicantSb-Kawasumi Laboratories, Inc.
Decision Date2025-03-26
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SB Knife Jr2 (MD-47702 and MD-47702L) is a medical device manufactured by Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-03-26 under approval number K241855. 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 Jr2 (MD-47702 and MD-47702L)?

SB Knife Jr2 (MD-47702 and MD-47702L) is a medical device that received FDA 510(k) clearance on 2025-03-26. It is manufactured by Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K241855.

When was SB Knife Jr2 (MD-47702 and MD-47702L) approved by the FDA?

SB Knife Jr2 (MD-47702 and MD-47702L) received FDA 510(k) clearance on 2025-03-26, under approval number K241855.

What company makes SB Knife Jr2 (MD-47702 and MD-47702L)?

SB Knife Jr2 (MD-47702 and MD-47702L) is manufactured by Sb-Kawasumi Laboratories, Inc..

What is the FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L)?

The FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L) is KNS.

Other Devices by Sb-Kawasumi Laboratories, Inc.

K220799K-SHIELD Zen K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

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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