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Ksea Steiner Electromechanic Morcellatort

by Karl Storz Endoscopy-America, Inc.

510(k) K946213

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 NumberK946213 Date27 Jan 1995ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Ksea Steiner Electromechanical Morcellatort is a device used in gastroenterology and urology procedures. It is designed for the mechanical fragmentation and removal of tissue during minimally invasive surgeries.

This device is supplied as a reusable instrument and requires appropriate cleaning and sterilization between uses. It was cleared through the FDA 510(k) traditional pathway under product code GCJ, with clearance granted on January 27, 1995, based on substantial equivalence to a predicate device.

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