Cleared Traditional

K000202 - CORTEK LAPAROSCOPES

K000202 is an FDA 510(k) clearance for CORTEK LAPAROSCOPES, manufactured by Cortek Endoscopy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K000202 · Cortek Endoscopy, Inc. · General & Plastic Surgery device
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Mar 2000
Decision
70d
Days
Class 2
Risk

K000202 is an FDA 510(k) clearance for the CORTEK LAPAROSCOPES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Cortek Endoscopy, Inc. (Palatine, US). The FDA issued a Cleared decision on March 31, 2000 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 - K000202

510(k) Number K000202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date March 31, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1068
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K000202.
KSEA MANHES PNEUMOTROCAR
K000769 · KARL STORZ Endoscopy-America, Inc. · Jun 2000
STRYKER IRRIGATION TUBE SET
K000493 · Stryker Endoscopy · May 2000
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
K000545 · Applied Medical Resources · May 2000
S57D DIGITAL OPERATING ROOM CAMERA
K000422 · Sopro · Mar 2000
S52D DIGITAL VIDEO LAPAROSCOPE
K000423 · Sopro · Mar 2000
S51D DIGITAL ENDOSCOPY CAMERA
K000424 · Sopro · Mar 2000