Skip to content

Trocars Trotec with Automatic Protective Mechanism

by Richard Wolf Medical Instruments Corp. 510(k)

Active United States

510(k) K003164

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003164 Date8 Jan 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 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 Trocars Trotec with Automatic Protective Mechanism are surgical instruments designed for laparoscopic procedures, specifically within the gynecological field. These devices facilitate the insertion of instruments or cameras into the abdominal cavity by creating a controlled pathway through the abdominal wall. The automatic protective mechanism enhances safety by preventing unintended penetration or injury during insertion.

These trocars are intended for single-use and are classified under product code HET (Hollow Needle, Trocar, or Similar Device). They are regulated under FDA 510(k) clearance (K003164) and are intended for use in sterile conditions within an operating room setting. The devices are supplied as reusable components for laparoscopic systems, adhering to safety standards for gynecologic laparoscopy. No additional regulatory approvals beyond the stated 510(k) clearance are implied.

Other devices from Richard Wolf Medical Instruments Corp.

See all devices from Richard Wolf Medical Instruments Corp. →