Cleared Traditional

K242666 - Fecobionics Anorectal System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K242666 · Gi Bionics, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
160d
Days
Class 2
Risk

K242666 is an FDA 510(k) clearance for the Fecobionics Anorectal System. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Gi Bionics, LLC (San Diego, US). The FDA issued a Cleared decision on February 12, 2025 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gi Bionics, LLC devices

Submission Details

510(k) Number K242666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2024
Decision Date February 12, 2025
Days to Decision 160 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Cygnus Regulatory
Natalie Eagleburger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03317938 Completed Interventional

Studies in Patients With Defecatory Disorders

Unraveling Anorectal Function and Biomarker Signatures in Patients Suffering From Subtypes of Defecatory Disorders

236
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Fecal Incontinence; Constipation
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Giome
Started 2017-08-14 → Primary completion 2024-12-31
Primary outcome
Decreased anorectal pressure assessed with the Fecobionics device
Secondary outcome
Decreased anorectal mechanical stress assessed with the Fecobionics device
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov