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ArchSinus Stent System
STS Medical Ltd. · Model 712-001 · UDI-DI 07290019367000
LYA
Prescription
1
510(k) clearances
203
Adverse events (3 deaths)
2
Recalls
105
Facilities
Description
The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention or revision surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-27 | GELITA MEDICAL GMBH | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
| 2006-07-11 | Porex Surgical, Inc. | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.