FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AceConnex Pre-Sutured Fascia
K Number: K213046
·
Decision Jun 27, 2023
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
2
Review Days
643
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Basic Information
- Device Name
- AceConnex Pre-Sutured Fascia
- K Number
- K213046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allosource
- Date Received
- September 22, 2021
- Decision Date
- June 27, 2023
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Allosource
| K Number | Device Name | ||
|---|---|---|---|
| K170957 | ReConnex Pre-Sutured Tendon | Mar 20, 2018 | Substantially Equivalent |