FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇦 Saudi Arabia
UNISILK
K Number: K042282
·
Decision Dec 1, 2004
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
40
Applicant Total
10
Review Days
99
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
- UNISILK
- K Number
- K042282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5030
- 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 1, 2004
- Product Code
- GAP
- 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 |
|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAP), ordered by most recent decision date.
Sofsilk Coated Braided Silk Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non absorbable Surgical Silk Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgical Sutures with or without Needle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SafePath Suturing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
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 |
| K042284 | UNIMIDE | Dec 3, 2004 | Substantially Equivalent |
| K042286 | UNIESTER C | Dec 1, 2004 | Substantially Equivalent |
| K042283 | UNIPRO | Dec 1, 2004 | Substantially Equivalent |