ALYTE Y-MESH GRAFT
FDA 510(k) clearance K101722 · decided 2011-04-01
Clearance details
- K-number
- K101722
- Device name
- ALYTE Y-MESH GRAFT
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-18
- Decision date
- 2011-04-01
- Days to decision
- 287 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
- Covington, GA, 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 |
| RESTORELLE L (K122440) | Coloplast Corp. | 2012-11-19 |
| AMS LARGE PORE POLYPROPHLENE MESH (K121805) | American Medical Systems | 2012-10-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |