Kerecis Reconstruct
FDA 510(k) K202430 · Kerecis Limited
510(k) numberK202430
Submission
- Device name
- Kerecis Reconstruct
- Applicant
- Kerecis Limited
Isafjordur, IS - Received
- August 25, 2020
- Decision date
- May 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXH – Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Other 510(k)s with product code OXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241)OXH · Special | Kerecis Limited | 07/15/2025SE |
| K171357 | SurgiMend PRS Meshed, Revize-XOXH · Special | Integra Lifesciences Corporation (Owner of Tei… | 06/07/2017SE |
| K160400 | Miromatrix Biological MeshOXH · Special | Miromatrix Medical, Inc. | 06/08/2016SE |
| K150341 | Miromatrix Biological Mesh RSOXH · Traditional | Miromatrix Medical, Inc. | 05/12/2015SE |
More from Miromatrix Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKGN · Special | 07/16/2025SE |
| K251844 | Kerecis SurgiBind (50241)OXH · Special | 07/15/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | 06/04/2025SE |
| K241080 | Kerecis Parvus (50207)KGN · Traditional | 08/21/2024SE |
| K213904 | Kerecis OralNPL · Traditional | 09/30/2022SE |
| K213231 | Kerecis SiliconeKGN · Traditional | 06/29/2022SE |
| K192612 | Kerecis Gingiva GraftNPL · Traditional | 11/13/2020SE |
| K190528 | MariGen Wound ExtraKGN · Traditional | 07/10/2019SE |
| K153364 | Kerecis SecureMeshOXE · Traditional | 08/19/2016SE |
| K132343 | Marigen Wound DressingKGN · Traditional | 10/23/2013SE |
Questions and answers
When was Kerecis Reconstruct cleared by the FDA?
Kerecis Reconstruct (K202430) received a 510(k) decision of Substantially Equivalent on May 2, 2021, 250 days after the submission was received.
What is the product code of K202430?
The FDA product code is OXH – Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery, a Class II (moderate risk) device regulated under 21 CFR 878.3300.