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FDA 510(k)

Multi-Functional Electrosurgical Knife

K-Number: K212999 · 2022-03-21

ApplicantAnrei Medical (Hangzhou) Co., Ltd.
Decision Date2022-03-21
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Multi-Functional Electrosurgical Knife is a medical device manufactured by Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-03-21 under approval number K212999. 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 Multi-Functional Electrosurgical Knife?

Multi-Functional Electrosurgical Knife is a medical device that received FDA 510(k) clearance on 2022-03-21. It is manufactured by Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K212999.

When was Multi-Functional Electrosurgical Knife approved by the FDA?

Multi-Functional Electrosurgical Knife received FDA 510(k) clearance on 2022-03-21, under approval number K212999.

What company makes Multi-Functional Electrosurgical Knife?

Multi-Functional Electrosurgical Knife is manufactured by Anrei Medical (Hangzhou) Co., Ltd..

What is the FDA product code for Multi-Functional Electrosurgical Knife?

The FDA product code for Multi-Functional Electrosurgical Knife is KNS.

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Other Devices by Anrei Medical (Hangzhou) Co., Ltd.

K201771Single Use Rotatable and Repositionable Hemoclip K192048Single Use Endoscope Valves Set K210917Single Use Injection Needle K202987Rescue Pulmonary Grasping Forceps K210660Stone Retrieval Balloon Catheter

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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