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FDA 510(k)

Renova RP Centesis Pump

K-Number: K221042 · 2023-04-19

ApplicantGi Supply, Inc.
Decision Date2023-04-19
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renova RP Centesis Pump is a medical device manufactured by Gi Supply, Inc.. It received FDA 510(k) clearance on 2023-04-19 under approval number K221042. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renova RP Centesis Pump?

Renova RP Centesis Pump is a medical device that received FDA 510(k) clearance on 2023-04-19. It is manufactured by Gi Supply, Inc.. The 510(k) number is K221042.

When was Renova RP Centesis Pump approved by the FDA?

Renova RP Centesis Pump received FDA 510(k) clearance on 2023-04-19, under approval number K221042.

What company makes Renova RP Centesis Pump?

Renova RP Centesis Pump is manufactured by Gi Supply, Inc..

What is the FDA product code for Renova RP Centesis Pump?

The FDA product code for Renova RP Centesis Pump is BTA.

Other Devices by Gi Supply, Inc.

K202376EverLift Submucosal Lifting Agent

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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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