510(k) K251844
- Device
- Kerecis SurgiBind (50241)
- Applicant
- Kerecis Limited
- 510(k) number
- K251844
- Product code
- OXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-15
- Date received
- 2025-06-16
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Skuli Magnusson
- Address
- Sundastraeti 38, 400 Isafjordur P.O. Box 151 Isafjordur IS 400 400
FDA Registration Numbers#
- 3016823837
- 1213643
- 1047843
- 3004170064
- 2024024
- 3016429246
- 3005920706
- 3004464325
- 3009882464
- 2030598
- 9680579
- 3012102437
- 3008868758
- 1000393132
- 2530154
- 1647098
- 3010400367
- 3006017180
- 3002719998
- 3002924436
- 3010155661
- 3004681519
- 3003418325
- 3005619880
- 3005636544
- 2124215
- 3010600625
- 1835959
Source Documents#
Other 510(k) Records For Product Code OXH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021-05-02 |
| K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 2017-06-07 |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016-06-08 |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015-05-12 |