Cleared Traditional

RESTORE (A.K.A. CAPSURE) (K971359) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K971359 · Nebl, Inc. · Gastroenterology & Urology device
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Nov 1997
Decision
217d
Days
Class 1
Risk

K971359 is an FDA 510(k) clearance for the RESTORE (A.K.A. CAPSURE). Classified as External Urethral Occluder, Urinary Incontinence-control, Female (product code MNG), Class I - General Controls.

Submitted by Nebl, Inc. (Worcester, US). The FDA issued a Cleared decision on November 14, 1997 after a review of 217 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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.

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Submission Details

510(k) Number K971359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date November 14, 1997
Days to Decision 217 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 130d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNG External Urethral Occluder, Urinary Incontinence-control, Female
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
Definition Intended To Prevent Or Decrease Episodes Of Urine Leakage In Women With Stress Incontinence. Occluder Is Applied To Urinary Meatus Through Suction Or Tape, Which Creates A Barrier For Urine Leakage. Occluding Device Such As A Cap, Suction Cup, Or Foam Pad. May Include Adhesive Gel Or Ointment.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.