Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015
FDA 510(k) K122968 · Coloplast Corp.
510(k) numberK122968
Submission
- Device name
- Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015
- Applicant
- Coloplast Corp.
Minneapolis, MN, US - Received
- September 25, 2012
- Decision date
- December 18, 2012
- 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 |
| K123028 | Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshOTO · Traditional | Caldera Medical, Inc. | 04/25/2013SE |
| 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 |
| K122794 | Upsylon Y MeshOTO · Traditional | Boston Scientific Corp | 12/18/2012SE |
| K122440 | Restorelle LOTO · Traditional | Coloplast Corp. | 11/19/2012SE |
More from Coloplast Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
Questions and answers
When was Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 cleared by the FDA?
Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 (K122968) received a 510(k) decision of Substantially Equivalent on December 18, 2012, 84 days after the submission was received.
What is the product code of K122968?
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.