# K983164: Restore (Aka RE/Stor)

- Pathway: 510(k) (Traditional)
- Applicant: Nebl, Inc.
- Decided: Mar 5, 1999 after 176 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
Longest line of descent: 2 generations back to K954215 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974600: Uromed Patch, Uromed Corp. (1998) Summary page 1.
- K971359: Restore (a.K.a. Capsure), Nebl, Inc. (1997) Summary page 1.

## Indications for use
The Restore device is indicated for the prevention or-decrease of eplsodes of urine leakage in women with stress incontinence.

Source page: https://510kreport.com/device/K983164
Methodology: https://510kreport.com/methodology