Data / Medical devices / United States / S. Jackson, Inc.
S. Jackson, Inc.: FDA-registered device maker in Alexandria, VA, United States, 5 510(k) clearances and 1 PMA approval
S. Jackson, Inc. is registered with the FDA (registration 1111225) in Alexandria, VA, United States. It lists 3 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated September 25, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1111225
- Address
- 15 Roth St, Alexandria, VA, United States, 22314
- Owner or operator
- S. JACKSON, INC. (1111225)
- Roles
- Manufacturer
- First device listed
- June 10, 1992
- Registered through
- 2026
- Brand names listed
- NYLAMID SUTURE, SUPRAFOIL, SUPRAMID, SUPRAMID EXTRA, SUPRAMID EXTRA SUTURE, SUPRAMID EXTRA SUTURES, SUPRAMID FOIL, SUPRAMID ORANGE-PEEL FOIL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 1997 | K973379 | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS | FTM | Substantially Equivalent | S. Jackson, Inc. | accessdata.fda.gov |
| December 17, 1993 | K931613 | SUPRAMID SUTURE | GAR | Substantially Equivalent | S. Jackson, Inc. | accessdata.fda.gov |
| December 17, 1993 | K931612 | NYLAMID SUTURE | GAR | Substantially Equivalent | S. Jackson, Inc. | accessdata.fda.gov |
| October 2, 1991 | K912429 | N80-838 SUPRAMID EXTRA SUTURE | GAR | Substantially Equivalent | S. Jackson, Inc. | accessdata.fda.gov |
| October 25, 1990 | K904052 | SUPRAMID EXTRA SUTURES | GAR | Substantially Equivalent | S. Jackson, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 5, 1983 | N80838 | SUPRAMID EXTRA SUTURES | GAR | 14 | January 26, 1990 | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical
- All makers of Template
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated September 25, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.