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FDA 510(k)

ORISE ProKnife

K-Number: K200404 · 2020-12-03

ApplicantBoston Scientific Corporation
Decision Date2020-12-03
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORISE ProKnife is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-12-03 under approval number K200404. 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 ORISE ProKnife?

ORISE ProKnife is a medical device that received FDA 510(k) clearance on 2020-12-03. It is manufactured by Boston Scientific Corporation. The 510(k) number is K200404.

When was ORISE ProKnife approved by the FDA?

ORISE ProKnife received FDA 510(k) clearance on 2020-12-03, under approval number K200404.

What company makes ORISE ProKnife?

ORISE ProKnife is manufactured by Boston Scientific Corporation.

What is the FDA product code for ORISE ProKnife?

The FDA product code for ORISE ProKnife is KNS.

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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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