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Laparoscopic Inst. (Scissors, Forceps, Needleholder)

by Endo Technic Corp.

510(k) K925079

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK925079 Date24 Aug 1994ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2265-2013 FDA Class II initiated 15 Jul 2013 on shared 510(k) K925079
    • Terminated Z-2264-2013 FDA Class II initiated 15 Jul 2013 on shared 510(k) K925079

    Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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, 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.

This device is a laparoscopic instrument set designed for minimally invasive surgical procedures. It includes scissors, forceps, and a needleholder, each engineered for precision manipulation of tissues, sutures, and other materials within the abdominal or pelvic cavities. The instruments are intended for use in gynecological and obstetric surgeries, where their ergonomic design facilitates delicate dissection, grasping, and suturing through small incisions. Their construction supports repeated use under sterile conditions, ensuring reliability in sterile environments.

The laparoscopic instrument set is supplied as a reusable surgical tool, requiring sterilization between uses to maintain infection control standards. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The instruments are intended for use in MRI-unsafe environments due to metallic components and must be stored in a clean, dry area to prevent contamination. No specific size details are provided in the regulatory data, but they are designed to fit standard laparoscopic ports and trocars.

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Questions

AI-generated answers, 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.

  • What is the primary use of this laparoscopic instrument set?

    This laparoscopic instrument set is specifically designed for minimally invasive surgical procedures in gynecological and obstetric surgeries. Its ergonomic and precise engineering allows for delicate tissue manipulation, grasping, and suturing through small incisions in the abdominal or pelvic cavities. The instruments are tailored to enhance surgical precision in these specialized fields.

  • Is this laparoscopic instrument set reusable or single-use?

    This laparoscopic instrument set is intended for reuse. It is constructed to withstand repeated use under sterile conditions, provided it undergoes proper sterilization between procedures. This design ensures reliability and infection control in sterile surgical environments.

  • What sterilization requirements apply to this device?

    Since this laparoscopic instrument set is reusable, it must be sterilized between uses to maintain infection control standards. The manufacturer recommends following standard sterilization protocols suitable for metallic surgical instruments to ensure safety and efficacy during surgical procedures.

  • Can this set be used in MRI environments?

    No, this laparoscopic instrument set is not intended for use in MRI environments. The presence of metallic components means it is classified as MRI-unsafe, so it should only be used in non-MRI settings to avoid interference or safety risks.

  • How should this instrument set be stored?

    This laparoscopic instrument set should be stored in a clean, dry area to prevent contamination. Proper storage conditions help maintain the integrity of the instruments and ensure they remain ready for use when needed. Avoid exposure to moisture or harsh chemicals that could compromise their sterility or functionality.