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FDA 510(k)

MANTIS Clip

K-Number: K221124 · 2022-08-04

ApplicantBoston Scientific Corporation
Decision Date2022-08-04
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANTIS Clip is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-08-04 under approval number K221124. 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 MANTIS Clip?

MANTIS Clip is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by Boston Scientific Corporation. The 510(k) number is K221124.

When was MANTIS Clip approved by the FDA?

MANTIS Clip received FDA 510(k) clearance on 2022-08-04, under approval number K221124.

What company makes MANTIS Clip?

MANTIS Clip is manufactured by Boston Scientific Corporation.

What is the FDA product code for MANTIS Clip?

The FDA product code for MANTIS 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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