ProGrip Self-Gripping Polypropylene Mesh
FDA 510(k) clearance K220540 · decided 2022-09-22
Clearance details
- K-number
- K220540
- Device name
- ProGrip Self-Gripping Polypropylene Mesh
- Applicant
- Covidien
- Decision
- Substantially Equivalent
- Date received
- 2022-02-25
- Decision date
- 2022-09-22
- Days to decision
- 209 days
- Clearance type
- Special
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mansfield, MA, 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 |
|---|---|---|
| ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956) | Sofradim Production | 2026-05-21 |
| Parietene™ Flat Sheet Mesh (K253125) | Medtronic - Sofradim Production | 2025-10-24 |
| Onflex™ Mesh (K251955) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 |
| Bard® Mesh; Bard® Mesh Pre-Shaped (K251557) | Davol, Inc. | 2025-06-12 |
| Parietene™ Macroporous Mesh (PPM5050 ) (K250869) | Sofradim Production | 2025-04-23 |
| Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098) | Davol, Inc. | 2025-04-09 |
| ProGrip™ Self-Gripping Polypropylene Mesh (K243315) | Sofradim Production | 2025-01-17 |
| 3DMax Light Mesh (K241250) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 |
| Progrip™ Self-Gripping Polypropylene Mesh (K232373) | Sofradim Production | 2024-01-18 |
| Bard 3DMax Mesh (K233402) | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 |
| T-Line® Hernia Mesh (K232924) | Deep Blue Medical Advances, Inc. | 2023-10-18 |
| Pitch PaSoft Tissue Reinforcement Device (K230671) | Xiros, Ltd. | 2023-05-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006) | Covidien | 1997-06-24 |
| MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005) | Covidien | 1995-12-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004) | Covidien | 1995-06-14 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003) | Covidien | 1994-06-17 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002) | Covidien | 1994-03-28 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001) | Covidien | 1993-09-10 |
| MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034) | Covidien | 1991-12-13 |