Restorelle Y Contour
FDA 510(k) K123914 · Coloplast A/S
510(k) numberK123914
Submission
- Device name
- Restorelle Y Contour
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- December 19, 2012
- Decision date
- March 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
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|---|---|---|---|
| K171271 | Polyform Synthetic MeshOTO · Special | Boston Scientific Corporation | 12/15/2017SE |
| K150023 | Vertessa Lite Y-MeshOTO · Traditional | Caldera Medical, Inc. | 04/06/2015SE |
| K150016 | Vertessa LiteOTO · Traditional | Caldera Medical, Inc. | 04/06/2015SE |
| K140116 | Restorelle Y Contour MeshOTO · Special | Coloplast A/S | 02/12/2014SE |
| K132061 | Restorelle M, Restorelle XLOTO · Special | Coloplast Corp. | 08/02/2013SE |
| K123028 | Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshOTO · Traditional | Caldera Medical, Inc. | 04/25/2013SE |
| K123337 | Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMOTO · Traditional | Caldera Medical | 02/21/2013SE |
| K122968 | Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015OTO · Traditional | Coloplast Corp. | 12/18/2012SE |
| K122794 | Upsylon Y MeshOTO · Traditional | Boston Scientific Corp | 12/18/2012SE |
| K122440 | Restorelle LOTO · Traditional | Coloplast Corp. | 11/19/2012SE |
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Questions and answers
When was Restorelle Y Contour cleared by the FDA?
Restorelle Y Contour (K123914) received a 510(k) decision of Substantially Equivalent on March 5, 2013, 76 days after the submission was received.
What is the product code of K123914?
The FDA product code is OTO – Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.