FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
Endoform Reconstructive Template - PLGA
K Number: K250598
·
Decision Jun 3, 2025
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
7
Review Days
95
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Basic Information
- Device Name
- Endoform Reconstructive Template - PLGA
- K Number
- K250598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aroa Biosurgery , Ltd.
- Date Received
- February 28, 2025
- Decision Date
- June 3, 2025
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Aroa Biosurgery , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231305 | Endoform Dental Membrane | Jan 23, 2024 | Substantially Equivalent |
| K223373 | Enivo | Apr 7, 2023 | Substantially Equivalent |
| K200502 | Myriad Particles | Mar 31, 2021 | Substantially Equivalent |
| K200413 | Symphony | Jul 29, 2020 | Substantially Equivalent |
| K183398 | Endoform Restella | Apr 11, 2019 | Substantially Equivalent |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Dec 4, 2018 | Substantially Equivalent |