# K122440: Restorelle L

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Nov 19, 2012 after 101 days
- Product code: OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931386 (1993). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120327: Vertessa, Caldera Medical, Inc. (2012) Summary page 1.

## Cited in the summary but kept off the family tree
- K101322: Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001, Joinsoon Electronics Mfg Co, Ltd. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K132061: Restorelle M, Restorelle XL (2013), 0 descendants of its own

## Recalls of this device
- Apr 12, 2013 · Class II · Z-1341-2013: Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

## Indications for use
Restorelle L is indicated for use as a bridging material for sacrocolposuspension/ sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K122440
Methodology: https://510kreport.com/methodology