FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tissue Approximation System (TAS)
K Number: K220980
·
Decision Jul 5, 2023
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
2
Review Days
457
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Basic Information
- Device Name
- Tissue Approximation System (TAS)
- K Number
- K220980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tas Medical, Inc.
- Date Received
- April 4, 2022
- Decision Date
- July 5, 2023
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Tas Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261484 | Tissue Approximation System | Jun 3, 2026 | Substantially Equivalent |