Cleared Special

K023053 - DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

K023053 is an FDA 510(k) clearance for DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 20-day FDA review.

K023053 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
20d
Days
Class 2
Risk

K023053 is an FDA 510(k) clearance for the DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on October 3, 2002 after a review of 20 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 - K023053

510(k) Number K023053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2002
Decision Date October 03, 2002
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 1431
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K023053.
ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · Guidant Corp. · Nov 2002
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
K023629 · Guidant Corporation, Cardiac Surgery · Nov 2002
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K022897 · Computer Motion, Inc. · Oct 2002
ADAPT OPEN ACCESS PORT, MODEL 41233
K021731 · Taut, Inc. · Aug 2002
ER150/M2
K021456 · World of Medicine Lemke GmbH · Aug 2002
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
K021290 · Vista Medical Technologies, Inc. · Jun 2002
K023053 · DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.