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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 the device name listed in this FDA 510(k) record. The listed applicant is Gi Bionics, LLC. It received FDA 510(k) clearance on 2025-02-12 under 510(k) 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. The listed applicant is Gi Bionics, LLC. The 510(k) number is K242666.

When did Fecobionics Anorectal System receive FDA 510(k) clearance?

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

Who is the listed applicant for Fecobionics Anorectal System?

The FDA 510(k) record lists Gi Bionics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fecobionics Anorectal System?

The FDA product code for Fecobionics Anorectal System is KLA.

Related Devices (Code: KLA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd Spa

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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