Cleared Traditional

COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS

K021237 · CooperSurgical, Inc. · Obstetrics & Gynecology
Apr 2003
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K021237 is an FDA 510(k) clearance for the COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by CooperSurgical, Inc. (Tuningen, DE). The FDA issued a Cleared decision on April 10, 2003, 357 days after receiving the submission on April 18, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K021237 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2002
Decision Date April 10, 2003
Days to Decision 357 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

Similar Devices — HET Laparoscope, Gynecologic (and Accessories)

All 337
SIRIUS Endoscope System (PR-SI-1230)
K250939 · Precision Robotics (Hong Kong) Limited · Aug 2025
i-Cut
K243821 · A.M.I. Agency For Medical Innovations GmbH · Apr 2025
SIRIUS Endoscope System
K221642 · Precision Robotics (Hong Kong) Limited · Dec 2022
Video Endoscopy System, 3D Video Endoscopy System
K210116 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2021
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · Olympus Medical Systems Corp. · Sep 2021
SurroundScope System
K210104 · 270surgical , Ltd. · Jul 2021