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FDA 510(k)

PINPOINT Endoscopic Fluorescence Imaging System

K-Number: K182606 · 2018-11-21

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2018-11-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PINPOINT Endoscopic Fluorescence Imaging System is a medical device manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2018-11-21 under approval number K182606. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINPOINT Endoscopic Fluorescence Imaging System?

PINPOINT Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K182606.

When was PINPOINT Endoscopic Fluorescence Imaging System approved by the FDA?

PINPOINT Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2018-11-21, under approval number K182606.

What company makes PINPOINT Endoscopic Fluorescence Imaging System?

PINPOINT Endoscopic Fluorescence Imaging System is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker).

What is the FDA product code for PINPOINT Endoscopic Fluorescence Imaging System?

The FDA product code for PINPOINT Endoscopic Fluorescence Imaging System is GCJ.

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Related PubMed Literature

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Other Devices by Novadaq Technologies Ulc. (Now A Part of Stryker)

K192174SPY Portable Handheld Imaging (SPY-PHI) System K190729SPY Portable Handheld Imaging (SPY-PHI) System K182907SPY Elite Intraoperative Perfusion Assessment System K202244SPY-PHI System with SPY-PHI Fluorescence Assessment Software K200737SPY Portable Handheld Imaging (SPY-PHI) System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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