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IntraStent II

by Intratherapeutics, Inc.

510(k) K990592

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK990592 Date1 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESU

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IntraStent II is a stent, drain, and dilator for the biliary ducts, classified under FDA product code FGE. It is designed to maintain patency of the biliary tree by providing mechanical support, facilitating bile flow, and reducing obstruction in the bile ducts. This device is intended for use in both gastroenterology and urology procedures, where biliary strictures or obstructions require intervention.

The IntraStent II is supplied as a single-use, non-sterile device and must be sterilized prior to use. It is intended for use in controlled clinical settings, such as operating rooms or endoscopy suites, where biliary interventions are performed. The device is regulated under FDA regulation 876.5010 and was cleared via a Traditional 510(k) pathway with a decision dated September 1, 1999. No specific MRI safety information is provided, and its dimensions or additional technical specifications are not detailed in the available data.

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