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FDA 510(k)

Fecobionics Anorectal System

K-Number: K242666 · 2025-02-12

ApplicantGi Bionics, LLC
Decision Date2025-02-12
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fecobionics Anorectal System is a medical device manufactured by Gi Bionics, LLC. It received FDA 510(k) clearance on 2025-02-12 under approval number K242666. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fecobionics Anorectal System?

Fecobionics Anorectal System is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Gi Bionics, LLC. The 510(k) number is K242666.

When was Fecobionics Anorectal System approved by the FDA?

Fecobionics Anorectal System received FDA 510(k) clearance on 2025-02-12, under approval number K242666.

What company makes Fecobionics Anorectal System?

Fecobionics Anorectal System is manufactured by Gi Bionics, LLC.

What is the FDA product code for Fecobionics Anorectal System?

The FDA product code for Fecobionics Anorectal System is KLA.

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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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