Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh
FDA 510(k) K123028 · Caldera Medical, Inc.
510(k) numberK123028
Submission
- Device name
- Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh
- Applicant
- Caldera Medical, Inc.
Agoura Hills, CA, US - Received
- September 28, 2012
- Decision date
- April 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
Other 510(k)s with product code OTO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K123914 | Restorelle Y ContourOTO · Special | Coloplast A/S | 03/05/2013SE |
| 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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| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…PAH · Traditional | 02/07/2020SE |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…PWJ · Traditional | 05/04/2018SE |
| K162201 | Desara TV, Desara Blue TVOTN · Traditional | 01/11/2017SE |
| K150023 | Vertessa Lite Y-MeshOTO · Traditional | 04/06/2015SE |
| K150016 | Vertessa LiteOTO · Traditional | 04/06/2015SE |
Questions and answers
When was Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh cleared by the FDA?
Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh (K123028) received a 510(k) decision of Substantially Equivalent on April 25, 2013, 209 days after the submission was received.
What is the product code of K123028?
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.