Cleared Traditional

K202244 - SPY-PHI System with SPY-PHI Fluorescenc...

K202244 is the FDA 510(k) clearance for SPY-PHI System with SPY-PHI Fluorescenc... by Novadaq Technologies Ulc. (Now A Part of Stryker). It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K202244 · Novadaq Technologies Ulc. (Now A Part of Stryker) · General & Plastic Surgery device
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Nov 2020
Decision
87d
Days
Class 2
Risk

K202244 is an FDA 510(k) clearance for the SPY-PHI System with SPY-PHI Fluorescence Assessment Software. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Novadaq Technologies Ulc. (Now A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on November 5, 2020 after a review of 87 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.

View all Novadaq Technologies Ulc. (Now A Part of Stryker) devices

Submission Details

510(k) Number K202244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2020
Decision Date November 05, 2020
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 Peers - OWN Confocal Optical Imaging

All 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K202244.
Cellvizio I.V.E. system with Confocal Miniprobes
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ActivSight Intraoperative Imaging System
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KARL STORZ ICG Imaging System
K202925 · KARL STORZ Endoscopy-America, Inc. · Dec 2020
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
K201399 · KARL STORZ Endoscopy-America, Inc. · Aug 2020
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
K200542 · Olympus Medical Systems Corp. · Jul 2020
SPY Portable Handheld Imaging (SPY-PHI) System
K200737 · Novadaq Technologies Ulc. (Now A Part of Stryker) · May 2020