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Hand Extractor Hector

by Karl Storz Endoscopy 510(k)

Active United States

510(k) K953109

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953109 Date25 Aug 1995ClearedStatusActive

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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A hand extractor device used in obstetrics and gynecology procedures. It is classified as a hysteroscope accessory under FDA device class 2.

The device received FDA 510(k) clearance K953109 on August 25, 1995, and is substantially equivalent to a legally marketed device. It is manufactured by Karl Storz Endoscopy and supplied as a reusable instrument requiring proper cleaning and maintenance per manufacturer instructions.

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Questions

AI-generated answers, 25 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 HAND EXTRACTOR HECTOR used for?

    The HAND EXTRACTOR HECTOR is a hand extractor device used in obstetrics and gynecology procedures, specifically classified as a hysteroscope accessory for use during hysteroscopic interventions.

  • Is the HAND EXTRACTOR HECTOR reusable or single-use?

    The HAND EXTRACTOR HECTOR is supplied as a reusable instrument, requiring proper cleaning and maintenance per the manufacturer's instructions to ensure safe and effective repeated use.

  • Who manufactures the HAND EXTRACTOR HECTOR and where is it authorized?

    The HAND EXTRACTOR HECTOR is manufactured by Karl Storz Endoscopy and received FDA 510(k) clearance K953109 on August 25, 1995, indicating it is substantially equivalent to a legally marketed device.