MINIMESH POLYPROPYLENE MESH
FDA 510(k) clearance K041632 · decided 2004-11-17
Clearance details
- K-number
- K041632
- Device name
- MINIMESH POLYPROPYLENE MESH
- Applicant
- Mpathy Medical Devices, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-16
- Decision date
- 2004-11-17
- Days to decision
- 154 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
- Farfield, CT, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| Polyform Synthetic Mesh (K171271) | Boston Scientific Corporation | 2017-12-15 |
| Vertessa Lite Y-Mesh (K150023) | Caldera Medical, Inc. | 2015-04-06 |
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| 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 |
| RESTORELLE L (K122440) | Coloplast Corp. | 2012-11-19 |
| AMS LARGE PORE POLYPROPHLENE MESH (K121805) | American Medical Systems | 2012-10-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx recall (Z-1481-2012) | Coloplast Manufacturing US, LLC | 2012-05-02 |