FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
High Strength Suture
K Number: K192637
·
Decision Mar 2, 2020
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
2
Review Days
160
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Basic Information
- Device Name
- High Strength Suture
- K Number
- K192637
- 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
- Yunyi (Beijing) Medical Device Co., Ltd.
- Date Received
- September 24, 2019
- Decision Date
- March 2, 2020
- 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 Yunyi (Beijing) Medical Device Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202291 | Button Loop | Jan 8, 2021 | Substantially Equivalent |