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Marionette SA, Model 001 001 & 001 002

by Kinetic Surgical, LLC

510(k) K072811

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 NumberK072811 Date21 Apr 2008ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Marionette SA, Model 001 001 & 001 002 is an endoscope and accessory device. It is classified as a laparoscope for use in general and plastic surgery.

This device is authorized under FDA 510(k) clearance K072811. It is categorized as a Class II medical device subject to special controls.

Other devices from Kinetic Surgical, LLC

Questions

AI-generated answers, 6 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 intended use of the Marionette SA?

    The Marionette SA is a laparoscope designed for use in general and plastic surgery procedures. It functions as an endoscope and accessory device to assist clinicians during surgical interventions.

  • What models are available for the Marionette SA?

    The Marionette SA is available in two specific configurations, identified as Model 001 001 and Model 001 002.

  • What is the regulatory status of the Marionette SA?

    This device is authorized under FDA 510(k) clearance K072811. It is classified as a Class II medical device and is subject to special controls as determined by the regulatory filing process.