RESTORELLE L
FDA 510(k) clearance K122440 · decided 2012-11-19
Clearance details
- K-number
- K122440
- Device name
- RESTORELLE L
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-10
- Decision date
- 2012-11-19
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- OTO
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Polyform Synthetic Mesh (K171271) | Boston Scientific Corporation | 2017-12-15 |
| Vertessa Lite Y-Mesh (K150023) | Caldera Medical, Inc. | 2015-04-06 |
| Vertessa Lite (K150016) | Caldera Medical, Inc. | 2015-04-06 |
| RESTORELLE Y CONTOUR MESH (K140116) | Coloplast A/S | 2014-02-12 |
| RESTORELLE M, RESTORELLE XL (K132061) | Coloplast Corp. | 2013-08-02 |
| VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (K123028) | Caldera Medical, Inc. | 2013-04-25 |
| RESTORELLE Y CONTOUR (K123914) | Coloplast A/S | 2013-03-05 |
| VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (K123337) | Caldera Medical | 2013-02-21 |
| UPSYLON Y MESH (K122794) | Boston Scientific Corp | 2012-12-18 |
| NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (K122968) | Coloplast Corp. | 2012-12-18 |
| AMS LARGE PORE POLYPROPHLENE MESH (K121805) | American Medical Systems | 2012-10-16 |
| ARTISYN Y-SHAPED MESH (K113205) | ETHICON, Inc. | 2012-06-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 D recall (Z-1341-2013) | Coloplast Manufacturing US, LLC | 2013-05-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |