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Surgical Trocar And Cannula

by Applied Vascular Devices, Inc.

510(k) K904379

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)SESE Substantially Equivalent · Traditional NumberK904379 Date21 Dec 1990ClearedStatusActive

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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Surgical Trocar And Cannula is a Class II medical device used for laparoscopic procedures in obstetrics and gynecology. It is designed to create access ports for surgical instruments during minimally invasive procedures.

This device is supplied as a single-use item and is not MRI compatible. It is regulated under FDA 510(k) clearance with product code HET and regulation number 884.1720. The device is manufactured by Applied Vascular Devices, Inc. and is available in various sizes as specified in the product documentation.

Other devices from Applied Vascular Devices, Inc.

See all devices from Applied Vascular Devices, Inc. →

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the Surgical Trocar And Cannula used for?

    The Surgical Trocar And Cannula is a Class II medical device designed for laparoscopic procedures in obstetrics and gynecology. It creates access ports for surgical instruments during minimally invasive procedures.

  • Is the Surgical Trocar And Cannula reusable or single-use?

    This device is supplied as a single-use item and is not intended for reuse. It must be discarded after a single procedure to ensure patient safety and maintain sterility.

  • What sizes and models of the Surgical Trocar And Cannula are available?

    The device is available in various sizes as specified in the product documentation. The specific sizes and models should be referenced in the product documentation provided by Applied Vascular Devices, Inc.

  • What is the regulatory status of the Surgical Trocar And Cannula?

    The device is regulated under FDA 510(k) clearance with product code HET and regulation number 884.1720. It has been determined to be substantially equivalent to other devices in this category.