Cortek Mini Laparoscope

FDA 510(k) K000199 · Cortek Endoscopy, Inc.

Substantially Equivalent

510(k) numberK000199

Submission

Device name
Cortek Mini Laparoscope
Applicant
Cortek Endoscopy, Inc.
Palatine, IL, US
Received
January 21, 2000
Decision date
April 13, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HET

510(k)DeviceApplicantDecision
K250939SIRIUS Endoscope System (PR-SI-1230)HET · Traditional Precision Robotics (Hong Kong) Limited08/29/2025SE
K243821i-CutHET · Traditional A.M.I. Agency For Medical Innovations GmbH04/25/2025SE
K221642SIRIUS Endoscope SystemHET · Traditional Precision Robotics (Hong Kong) Limited12/12/2022SE
K210116Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional Surgnova Healthcare Technologies (Zhejiang) Co.…10/13/2021SE
K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional Olympus Medical Systems Corp.09/17/2021SE
K210104SurroundScope SystemHET · Traditional 270surgical , Ltd.07/08/2021SE
K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional Schoelly Fiberoptic GmbH03/12/2021SE
K2002164K UHD Camera SystemHET · Traditional Scivita Medical Technology Co., Ltd.08/21/2020SE
K200638LAP-iX Suction IrrigationHET · Special Sejong Medical Co., Ltd.04/03/2020SE
K190190WV1 EndoscopeHET · Traditional 270surgical , Ltd.11/01/2019SE

More from 270surgical , Ltd.

510(k)DeviceDecision
K000198Cortek ArthroscopeHRX · Traditional 04/11/2000SE
K000202Cortek LaparoscopesGCJ · Traditional 03/31/2000SE
K000200Cortek UretheroscopeFGB · Traditional 03/03/2000SE
K000197Cortek CystoscopeFAJ · Traditional 03/03/2000SE

Questions and answers

When was Cortek Mini Laparoscope cleared by the FDA?

Cortek Mini Laparoscope (K000199) received a 510(k) decision of Substantially Equivalent on April 13, 2000, 83 days after the submission was received.

What is the product code of K000199?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.