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Fecobionics Anorectal System

by Gi Bionics, LLC

510(k) K242666

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242666 Date12 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KLA
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fecobionics Anorectal System is a diagnostic device classified as a monitor for anorectal motility and esophageal motility studies. It is designed to evaluate anorectal pressure and defecatory function, providing objective measurements for clinical assessment of gastrointestinal and urological conditions.

This system is intended for use in clinical settings, such as gastroenterology and urology, and has received FDA 510(k) clearance under the classification of Class II (KLA). Supplied as a reusable medical device, it is regulated under FDA regulation number 876.1725 and is intended for professional healthcare use only. No specific sterility or single-use designation is noted in the regulatory data.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical specialties primarily use the Fecobionics Anorectal System, and why is it relevant to them?

    The Fecobionics Anorectal System is primarily used in gastroenterology and urology specialties. It is designed to evaluate anorectal pressure and defecatory function, providing objective measurements for diagnosing gastrointestinal and urological conditions such as motility disorders, fecal incontinence, or pelvic floor dysfunction. Clinicians in these fields rely on it for precise diagnostic assessments.

  • Is the Fecobionics Anorectal System intended for single-use or reusable applications, and how does this affect its clinical workflow?

    The Fecobionics Anorectal System is reusable, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. This makes it cost-effective for hospitals and clinics performing multiple diagnostic procedures, as it eliminates the need for disposable alternatives. However, proper sterilization protocols must be followed to ensure patient safety between uses.

  • What types of motility studies can this system perform, and how does it differ from other anorectal diagnostic tools?

    The Fecobionics Anorectal System is specifically designed for anorectal and esophageal motility studies, allowing clinicians to measure pressure and function in these areas. Unlike general-purpose manometry systems, it is tailored for objective assessment of defecatory mechanics, which helps differentiate it from broader diagnostic tools by focusing on specialized gastrointestinal and urological evaluations.

  • How is the device regulated, and what does its FDA clearance status imply for healthcare providers?

    The Fecobionics Anorectal System has received FDA 510(k) clearance under the classification of Class II (KLA), indicating it is deemed substantially equivalent to a legally marketed predicate device. This clearance confirms its safety and effectiveness for professional healthcare use only, ensuring providers can rely on it for clinical diagnostics in gastroenterology and urology. The regulatory route confirms it meets FDA standards for anorectal and esophageal motility monitoring.