Data / Medical devices / Israel / STS Medical Ltd
STS Medical Ltd: FDA-registered device maker in Petach Tikva Tel Aviv, Israel, 1 510(k) clearance
STS Medical Ltd is registered with the FDA (registration 3014345718) in Petach Tikva Tel Aviv, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014345718
- Address
- 37 Amal Street Kyriat Arie, Petach Tikva Tel Aviv, Israel, 4951337
- Owner or operator
- STS Medical (10057179)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 4, 2018
- Registered through
- 2026
- Brand names listed
- Composite Removable Sinus Stent
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 15, 2017 | K170913 | Composite Removable Sinus Stent System | LYA | Substantially Equivalent | Sts Medical | accessdata.fda.gov |
Compare with other makers
Updated December 15, 2017. 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.