Cleared Traditional

K080051 - VIRTUAL PORTS ENDOCLEAR SYSTEM

K080051 is an FDA 510(k) clearance for VIRTUAL PORTS ENDOCLEAR SYSTEM, manufactured by Virtual Ports, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K080051 · Virtual Ports, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
73d
Days
Class 2
Risk

K080051 is an FDA 510(k) clearance for the VIRTUAL PORTS ENDOCLEAR SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Virtual Ports, Ltd. (Binyamina, IL). The FDA issued a Cleared decision on March 21, 2008 after a review of 73 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.

FDA 510(k) Submission Details - K080051

510(k) Number K080051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2008
Decision Date March 21, 2008
Days to Decision 73 days
Submission Type Traditional
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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 1428
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K080051.
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
K080654 · PAJUNK GmbH Medizintechnologie · May 2008
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE
K072613 · Micro Invasive Technology, Inc. · Apr 2008
MARIONETTE SA, MODEL 001 001 & 001 002
K072811 · Kinetic Surgical, LLC · Apr 2008
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K080155 · Intuitive Surgical, Inc. · Mar 2008
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
K073279 · Visionsense, Ltd. · Mar 2008
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
K073719 · Advanced Surgical Concepts · Jan 2008
K080051 · VIRTUAL PORTS ENDOCLEAR SYSTEM
Download PDF FDA Summary Virtual Ports, Ltd.