FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPRAMID EXTRA SUTURES
K Number: K904052
·
Decision Oct 25, 1990
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
16
Review Days
57
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
- SUPRAMID EXTRA SUTURES
- K Number
- K904052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- S. Jackson, Inc.
- Date Received
- August 29, 1990
- Decision Date
- October 25, 1990
- 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 S. Jackson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080216 | SUPRAMESH EXTRA | Sep 15, 2008 | Substantially Equivalent |
| K973379 | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | Sep 25, 1997 | Substantially Equivalent |
| K931614 | MOPYLEN SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931613 | SUPRAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K931612 | NYLAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K922630 | MOPYLEN | Oct 20, 1992 | Substantially Equivalent |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | Oct 2, 1991 | Substantially Equivalent |
| K852011 | NYLAMID MESH PAD FULL & HALF | Jun 11, 1985 | Substantially Equivalent |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | Aug 16, 1983 | Substantially Equivalent |
| K831727 | QUARTER GLOBE CAPS | Aug 12, 1983 | Substantially Equivalent |