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Stryker Heated Insufflator Tube Set

by Stryker Corp. 510(k)

Active United States

510(k) K003792

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003792 Date21 Feb 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1728-2019 FDA Class II initiated 7 Mar 2019

    The heated tube sets were consistently leaking and detaching from the cassette.

Specification

510(k)

510(k) Number
FDA Product Code
HIF
Device Class
Class II
Regulation
21 CFR Part 884.1730
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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