SurgiMend PRS Meshed, Revize-X
FDA 510(k) clearance K171357 · decided 2017-06-07
Clearance details
- K-number
- K171357
- Device name
- SurgiMend PRS Meshed, Revize-X
- Applicant
- Integra Lifesciences Corporation (Owner of Tei Biosciences)
- Decision
- Substantially Equivalent
- Date received
- 2017-05-09
- Decision date
- 2017-06-07
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OXH
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Kerecis SurgiBind (50241) (K251844) | Kerecis Limited | 2025-07-15 |
| Kerecis Reconstruct (K202430) | Kerecis Limited | 2021-05-02 |
| Miromatrix Biological Mesh (K160400) | Miromatrix Medical, Inc. | 2016-06-08 |
| Miromatrix Biological Mesh RS (K150341) | Miromatrix Medical, Inc. | 2015-05-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Sem recall (Z-2070-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 recall (Z-2084-2023) | TEI Biosciences, Inc. | 2024-09-30 |