Cleared Special

K191579 - Voyant System

K191579 is an FDA 510(k) clearance for Voyant System, manufactured by Viseon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HRX cleared through the Special 510(k) pathway after a 27-day FDA review.

K191579 · Viseon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
27d
Days
Class 2
Risk

K191579 is an FDA 510(k) clearance for the Voyant System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Viseon, Inc. (Irvine, US). The FDA issued a Cleared decision on July 11, 2019 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.1100 - 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 - K191579

510(k) Number K191579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date July 11, 2019
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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 - HRX Arthroscope

All 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K191579.
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · Smith & Nephew, Inc. · Sep 2019
Pegasus System
K191345 · A.M. Surgical, Inc. · Jul 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · Stryker Corp. · Jul 2019
Nuvis Battery Arthroscope
K191594 · Integrated Endoscopy, Inc. · Jul 2019
HydroCision TenJet Device
K190804 · Hydrocision, Inc. · Jun 2019
MEDINAUT Plus
K182287 · Imedicom Co., Ltd. · Apr 2019
K191579 · Voyant System
Download PDF FDA Summary Viseon, Inc.