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FDA 510(k)

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

K-Number: K202244 · 2020-11-05

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2020-11-05
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K202244. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K202244.

When did SPY-PHI System with SPY-PHI Fluorescence Assessment Software receive FDA 510(k) clearance?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software received FDA 510(k) clearance on 2020-11-05, under 510(k) number K202244.

Who is the listed applicant for SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

The FDA 510(k) record lists Novadaq Technologies Ulc. (Now A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

The FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software is OWN.

Other records listing Novadaq Technologies Ulc. (Now A Part of Stryker) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200737SPY Portable Handheld Imaging (SPY-PHI) SystemK192174SPY Portable Handheld Imaging (SPY-PHI) SystemK190729SPY Portable Handheld Imaging (SPY-PHI) SystemK182907SPY Elite Intraoperative Perfusion Assessment SystemK182606PINPOINT Endoscopic Fluorescence Imaging System

Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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