Cleared Traditional

K000199 - CORTEK MINI LAPAROSCOPE

K000199 is an FDA 510(k) clearance for CORTEK MINI LAPAROSCOPE, manufactured by Cortek Endoscopy, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K000199 · Cortek Endoscopy, Inc. · Obstetrics & Gynecology device
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Apr 2000
Decision
83d
Days
Class 2
Risk

K000199 is an FDA 510(k) clearance for the CORTEK MINI LAPAROSCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Cortek Endoscopy, Inc. (Palatine, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cortek Endoscopy, Inc. devices

FDA 510(k) Submission Details - K000199

510(k) Number K000199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date April 13, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 160d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 226
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K000199.
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · Richard Wolf Medical Instruments Corp. · Jan 2001
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · Xomed, Inc. · Jun 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · Ethicon Endo-Surgery, Inc. · May 2000
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K992481 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Mar 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Mar 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000