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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 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 2018-11-21 under 510(k) 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. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K182606.

When did PINPOINT Endoscopic Fluorescence Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for PINPOINT Endoscopic Fluorescence Imaging System?

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 PINPOINT Endoscopic Fluorescence Imaging System?

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

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.

K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareK200737SPY Portable Handheld Imaging (SPY-PHI) SystemK192174SPY Portable Handheld Imaging (SPY-PHI) SystemK190729SPY Portable Handheld Imaging (SPY-PHI) SystemK182907SPY Elite Intraoperative Perfusion Assessment System

Related Devices (Code: GCJ)

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

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