Data / Medical devices / United States / Specialty Surgical Products, Inc.
Specialty Surgical Products, Inc.: FDA-registered device maker in Victor, MT, United States, 2 510(k) clearances
Specialty Surgical Products, Inc. is registered with the FDA (registration 3031984) in Victor, MT, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 12, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031984
- FEI number
- 3001237472
- Address
- 1123 North U.S. Hwy. 93, Victor, MT, United States, 59875
- Owner or operator
- SPECIALTY SURGICAL PRODUCTS, INC. (9031344)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 1, 1998
- Registered through
- 2026
- Brand names listed
- Clear Cast Silicone Silo Bag, PEDIATRIC ANAL DILATOR, Single Use Mammary Sizer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Rectal | FFP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mammary Sizer | MRD | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 12, 1999 | K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | MRD | Substantially Equivalent | Specialty Surgical Products, Inc. | accessdata.fda.gov |
| November 4, 1997 | K973082 | VENTRAL WALL DEFECT REDUCTION SILO | FTL | Substantially Equivalent | Specialty Surgical Products, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 12, 1999. 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.