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Laparoscopy Sets, Needle Holders, Blunt Shears

by Imtec Corp.

510(k) K923259

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 NumberK923259 Date11 Apr 1994ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

These laparoscopy sets consist of specialized instruments designed for minimally invasive procedures that access the abdominal cavity through small ports. The collection includes needle holders and blunt shears to facilitate precise tissue handling and surgical intervention without the need for large incisions.

This device is authorized under FDA 510(k) clearance K923259. It is intended for use in gynecologic surgical settings as a laparoscope accessory.

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Questions

AI-generated answers, 24 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 are these laparoscopy sets used for?

    These sets are intended for use in gynecologic surgical settings as accessories for a laparoscope. They are designed to facilitate precise tissue handling and surgical intervention through small ports, allowing for minimally invasive access to the abdominal cavity.

  • What specific instruments are included in the collection?

    The collection consists of specialized instruments, specifically needle holders and blunt shears, which are designed to assist surgeons in performing procedures without the need for large incisions.

  • Is this device authorized for clinical use?

    Yes, this device is authorized under FDA 510(k) clearance K923259. This clearance indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.