Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSts Medical
US
Last updated May 23, 2026
What Sts Medical makes
Sts Medical manufactures intranasal splints designed for sinus support, including non-biodegradable stents for temporary or removable use. Their portfolio includes systems like the ArchSinus Stent and a composite removable sinus stent, intended for nasal passage stabilization during medical procedures.
These devices are classified as Class I under regulatory frameworks, with authorisations listed through FDA pathways including 510(k) submissions and the Unique Device Identifier (UDI) program. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sts Medical manufacture?
Sts Medical specializes in intranasal splints, specifically non-biodegradable devices. These are designed to provide sinus support, such as the ArchSinus Stent System and the Composite Removable Sinus Stent System, which are intended for temporary or removable use in stabilizing nasal passages during medical procedures.
Where is Sts Medical based?
Sts Medical is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries or databases list Sts Medical’s devices?
Sts Medical’s devices are listed in the FDA’s 510(k) clearance pathway and the Unique Device Identifier (UDI) program. These registries are used to track and authorize medical devices in the United States, ensuring compliance with regulatory requirements.
How are Sts Medical’s devices classified under regulatory frameworks?
Sts Medical’s devices, such as intranasal splints, are classified as Class I under regulatory frameworks. This classification is typically assigned to low-risk medical devices that pose minimal potential harm to patients, though individual device authorizations are still required through pathways like the FDA’s 510(k) process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ArchSinus Stent System | 712-001 | FDA UDI | Class I | Active |
| Composite Removable Sinus Stent System | K170913 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- STS Medical Ltd Petach Tikva Tel Aviv · IL FEI 3014345718