Data / Medical devices / United States / Mastel Surgical Inc.
Mastel Surgical Inc.: FDA-registered device maker in Schiller Park, IL, United States, 1 510(k) clearance
Mastel Surgical Inc. is registered with the FDA (registration 3042624965) in Schiller Park, IL, United States. It lists 7 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
- 3042624965
- Address
- 9207 Ivanhoe St, Schiller Park, IL, United States, 60176
- Owner or operator
- Mastel Surgical Inc. (10094842)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 29, 2025
- Registered through
- 2027
- Brand names listed
- Atomizer, K-Wire Rack, Latch Accessory For Instrument Tray, Mesh tray, Pouch Rack, Powder Blower, SteriBest, SteriBest Sterilization Tray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blower, Powder, Ent | KCL | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer, Repackager or relabeler, Specification developer | 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 Syringe, Ent
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Tray, Surgical, Instrument
- All makers of Blower, Powder, Ent
- 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.