FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇦 Saudi Arabia
UNIMIDE
K Number: K042284
·
Decision Dec 3, 2004
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
10
Review Days
101
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UNIMIDE
- K Number
- K042284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United Medical Industries Co. , Ltd.
- Date Received
- August 24, 2004
- Decision Date
- December 3, 2004
- 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
Other 510(k) clearances with the same product code (GAR), ordered by most recent decision date.
Tissue Approximation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tissue Approximation System (TAS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Golnit Nylon Monofilament Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non Absorbable Surgical Nylon Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Crownjun Nylon Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REXLON, REXSIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by United Medical Industries Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K072646 | UNICAPRONE | Nov 7, 2007 | Substantially Equivalent |
| K072644 | UNICRYL QUICK | Nov 7, 2007 | Substantially Equivalent |
| K072645 | UNIGLACTIN | Nov 7, 2007 | Substantially Equivalent |
| K042287 | UNIPLAIN & UNICHROM | Sep 7, 2005 | Substantially Equivalent |
| K042288 | UNICRYL | Dec 27, 2004 | Substantially Equivalent |
| K042285 | UNICRYL M | Dec 10, 2004 | Substantially Equivalent |
| K042286 | UNIESTER C | Dec 1, 2004 | Substantially Equivalent |
| K042283 | UNIPRO | Dec 1, 2004 | Substantially Equivalent |
| K042282 | UNISILK | Dec 1, 2004 | Substantially Equivalent |