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FDA 510(k)

Resolution 360™ ULTRA Clip

K-Number: K193424 · 2020-09-01

ApplicantBoston Scientific Corporation
Decision Date2020-09-01
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Resolution 360™ ULTRA Clip is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-09-01 under approval number K193424. 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 360™ ULTRA Clip?

Resolution 360™ ULTRA Clip is a medical device that received FDA 510(k) clearance on 2020-09-01. It is manufactured by Boston Scientific Corporation. The 510(k) number is K193424.

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

Resolution 360™ ULTRA Clip received FDA 510(k) clearance on 2020-09-01, under approval number K193424.

What company makes Resolution 360™ ULTRA Clip?

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

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

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

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Related Devices (Code: 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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