Cleared Special

K222468 - ArcTO Transobturator Sling System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222468 · Urocure, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2022
Decision
30d
Days
Class 2
Risk

K222468 is an FDA 510(k) clearance for the ArcTO Transobturator Sling System. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by Urocure, LLC (Minneapolis, US). The FDA issued a Cleared decision on September 15, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Urocure, LLC devices

Submission Details

510(k) Number K222468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2022
Decision Date September 15, 2022
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Libramedical, Inc.
Denise Lenz

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.

Regulatory Peers - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 64
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