Cleared Abbreviated

K021290 - VISTA VISUALIZATION SYSTEM

K021290 is an FDA 510(k) clearance for VISTA VISUALIZATION SYSTEM, manufactured by Vista Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Abbreviated 510(k) pathway after a 66-day FDA review.

K021290 · Vista Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
66d
Days
Class 2
Risk

K021290 is an FDA 510(k) clearance for the VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE.... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Vista Medical Technologies, Inc. (Westborough, US). The FDA issued a Cleared decision on June 28, 2002 after a review of 66 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vista Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K021290

510(k) Number K021290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2002
Decision Date June 28, 2002
Days to Decision 66 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Standards-based clearance path.

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 724
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K021290.
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
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ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · Guidant Corp. · Nov 2002
DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
K023053 · Smith & Nephew, Inc. · Oct 2002
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K020428 · Ethicon Endo-Surgery, Inc. · Mar 2002
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
K013952 · Intuitive Surgical, Inc. · Feb 2002
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
K014047 · Applied Medical Resources Corp. · Feb 2002