# K971359: Restore (a.K.a. Capsure)

- Pathway: 510(k) (Traditional)
- Applicant: Nebl, Inc.
- Decided: Nov 14, 1997 after 217 days
- Product code: MNG (External Urethral Occluder, Urinary Incontinence-Control, Female)
- Device class: 1
- Regulation: 21 CFR 876.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NEBL CapAid Device: named in the summary without a submission number
- (no number) ASI/Uromed Miniguard: named in the summary without a submission number

## Most influential descendants
- K983164: Restore (Aka RE/Stor) (1999), 0 descendants of its own

## Indications for use
The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.

Source page: https://510kreport.com/device/K971359
Methodology: https://510kreport.com/methodology