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FDA 510(k)

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

K-Number: K222503 · 2022-09-14

ApplicantBoston Scientific Corporation
Decision Date2022-09-14
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-14 under approval number K222503. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip?

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K222503.

When was Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip approved by the FDA?

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip received FDA 510(k) clearance on 2022-09-14, under approval number K222503.

What company makes Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip?

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip is manufactured by Boston Scientific Corporation.

What is the FDA product code for Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip?

The FDA product code for Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip is PKL.

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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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