Cleared Special

K020428 - ENDOPATH DILATING TIP TROCAR, MODEL #512XD

K020428 is an FDA 510(k) clearance for ENDOPATH DILATING TIP TROCAR, manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 24-day FDA review.

K020428 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
24d
Days
Class 2
Risk

K020428 is an FDA 510(k) clearance for the ENDOPATH DILATING TIP TROCAR, MODEL #512XD. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020428

510(k) Number K020428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date March 04, 2002
Days to Decision 24 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 1400
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K020428.
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K013952 · Intuitive Surgical, Inc. · Feb 2002
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K014047 · Applied Medical Resources Corp. · Feb 2002
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K014005 · Apple Medical Corp. · Feb 2002
K020428 · ENDOPATH DILATING TIP TROCAR, MODEL #512XD
Download PDF FDA Summary Ethicon Endo-Surgery,…