FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
WEGO-PGA RAPID
K Number: K183004
·
Decision Jan 28, 2019
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- WEGO-PGA RAPID
- K Number
- K183004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foosin Medical Supplies Inc., Ltd.
- Date Received
- October 30, 2018
- Decision Date
- January 28, 2019
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Foosin Medical Supplies Inc., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201139 | WEGO-PDO Barbed Suture | Oct 20, 2020 | Substantially Equivalent |
| K193209 | Wego-Stainless Steel | Feb 19, 2020 | Substantially Equivalent |
| K183001 | WEGO-PGLA RAPID | Jan 28, 2019 | Substantially Equivalent |
| K170842 | WEGO-PTFE | Jul 31, 2017 | Substantially Equivalent |
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Nov 14, 2014 | Substantially Equivalent |
| K130735 | SYNTHETIC ABSORBABLE SUTURE | Jan 14, 2014 | Substantially Equivalent |
| K130737 | SYNTHETIC ABSORBABLE SUTURE | Jan 14, 2014 | Substantially Equivalent |