Skip to content

Kronner Manipujector

by Unimar, Inc.

510(k) K904473

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904473 Date14 Dec 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HES
Device Class
Class II
Regulation
21 CFR Part 884.1300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

The Kronner Manipujector is a sterile, single-use, curved double lumen device indicated for procedures requiring manipulation of the uterus such as minilap tubal ligation, laparoscopic tubal occlusion, diagnostic laparoscopy or operative laparoscopy. It seals the internal cervical os against the cervical back-flow of fluid or gas. The device features a unique glide action with a pinch-grip handle designed to eliminate time-consuming tasks required for removal, reinsertion, and reinflation during intra-operative repositioning.

The Kronner Manipujector is supplied as a sterile, single-use device. It is classified under product code HES and has received FDA 510(k) clearance with decision code SESE. The device is intended for use in obstetrics and gynecology procedures and is manufactured by Unimar, Inc. with authorization number K904473.

Other devices from Unimar, Inc.

See all devices from Unimar, Inc. →

Questions

AI-generated answers, 28 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 Kronner Manipujector used for?

    The Kronner Manipujector is a sterile, single-use device indicated for procedures requiring manipulation of the uterus, such as minilap tubal ligation, laparoscopic tubal occlusion, diagnostic laparoscopy, or operative laparoscopy. It seals the internal cervical os against cervical back-flow of fluid or gas.

  • How is the Kronner Manipujector supplied?

    The Kronner Manipujector is supplied as a sterile, single-use device. It is classified under product code HES and has received FDA 510(k) clearance with decision code SESE. The device is manufactured by Unimar, Inc. with authorization number K904473.

  • What are the key features of the Kronner Manipujector?

    The device features a unique glide action with a pinch-grip handle designed to eliminate time-consuming tasks required for removal, reinsertion, and reinflation during intra-operative repositioning. This design enhances efficiency during gynecological procedures.

  • Is the Kronner Manipujector reusable?

    No, the Kronner Manipujector is designed as a sterile, single-use device. It should not be reused on multiple patients as this could compromise sterility and device performance.