Home › TAEWOONGMEDICAL.CO.,LTD › Niti-S SPAXUS Stent

Niti-S SPAXUS Stent

TAEWOONGMEDICAL.CO.,LTD · Model SS1002FW · UDI-DI 08809909422294

PCU QXH Prescription

510(k) clearances

2,138

Adverse events (65 deaths)

Recalls

Facilities

Description

The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent designed for the indications listed below. The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the Niti-S SPAXUS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The Niti-S SPAXUS Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery. The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent. The stent is constructed from nickel-titanium alloy (nitinol), which provides flexibility, durability, and self-expansion properties. Its bi-flange design ensures stable lumen apposition and minimizes the risk of migration. A complete silicone coating prevents leakage during drainage and facilitates the safe removal of the device. Radiopaque markers made of platinum/iridium and stainless steel enhance visibility under fluoroscopic guidance, aiding precise placement and monitoring. The device is provided sterile to the end user and has a 2-year shelf-life.

Recalls

Date	Firm	Reason
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul
2020-12-01	Boston Scientific Corporation	The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resul

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.