Data / Medical devices / United States / Mastel Surgical Inc.
Mastel Surgical Inc.: FDA-registered device maker in Rapid City, SD, United States, 1 510(k) clearance
Mastel Surgical Inc. is registered with the FDA (registration 2184066) in Rapid City, SD, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2184066
- FEI number
- 1000115761
- Address
- 1550 Samco Rd, Rapid City, SD, United States, 57702
- Owner or operator
- MASTEL SURGICAL INC. (9005641)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- June 26, 1992
- Registered through
- 2027
- Brand names listed
- K-WIRE RACK, Latch Accessory For Instrument Tray, MICROMETER CONTROL, OPTICAL ZONE MARKERS, Pouch Rack; SteriBest; Stringer, SteriBest Sterilization Tray, SteriBest Sterilization Tray; Mesh Tray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K253187 | SteriBest® Sterilization Tray System | KCT | Substantially Equivalent | Mastel Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Marker, Ocular
- All makers of Knife, Ophthalmic
- All makers of Tray, Surgical, Instrument
- All makers of Tray, Surgical
Updated June 18, 2026. 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.