Cleared Traditional

K191851 - VS3-IR

K191851 is the FDA 510(k) clearance for VS3-IR by Medtronic. It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K191851 · Medtronic · General & Plastic Surgery device
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Nov 2019
Decision
138d
Days
Class 2
Risk

K191851 is an FDA 510(k) clearance for the VS3-IR. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Medtronic (Petach Tikva, Hamerkaz, IL). The FDA issued a Cleared decision on November 25, 2019 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic devices

Submission Details

510(k) Number K191851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2019
Decision Date November 25, 2019
Days to Decision 138 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
23d slower than avg
Panel avg: 115d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 Consultant

Arazy Group Consultants, Inc.
Ray Kelly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OWN Confocal Optical Imaging

All 42
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K192292 · Stryker · Nov 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K192174 · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM
K191046 · Stryker · May 2019