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Tubal Occlusion Inserter/Laparoscope

by Kli

510(k) K771960

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 NumberK771960 Date25 Oct 1977ClearedStatusActive

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  • Withdrawn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, 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.

This device is a tubal occlusion inserter/laparoscope, classified as a laparoscope, gynecologic (and accessories) under product code HET. It is a Class II medical device subject to special controls.

It received FDA 510(k) clearance (K771960) on October 25, 1977, following a traditional submission. The device is manufactured by Kli in McHenry, Illinois, United States.

Other devices from Kli

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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 tubal occlusion inserter/laparoscope used for?

    This device is a tubal occlusion inserter/laparoscope, classified as a laparoscope, gynecologic (and accessories) under product code HET, and is used in gynecologic procedures for tubal occlusion and laparoscopic visualization.

  • Who manufactures the tubal occlusion inserter/laparoscope and where is it made?

    The device is manufactured by Kli in McHenry, Illinois, United States, as specified in the device data.

  • What regulatory pathway was used for the tubal occlusion inserter/laparoscope?

    The device received FDA 510(k) clearance via a traditional submission, with clearance granted on October 25, 1977, under K771960, and is classified as a Class II medical device subject to special controls.

  • What is the product code and device classification for the tubal occlusion inserter/laparoscope?

    The device is classified under product code HET as a laparoscope, gynecologic (and accessories), and is a Class II medical device, as indicated in the openfda and product_code fields.