Pinpoint Endoscopic Light Source and Video Camera

FDA PMA

Class III (US FDA PMA)

PMA P950042

by Novadaq Technologies Inc

Identity

Trade Name: PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA FDA PMA
Generic Name: SYSTEM, IMAGING, FLUORESCENCE FDA PMA

Identifiers

PMA Number: P950042 FDA PMA
FDA Product Code: MRK FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Ear, Nose, Throat FDA PMA
FDA Decision: APPR Approved FDA PMA

The Pinpoint Endoscopic Light Source and Video Camera is a System, Imaging, Fluorescence device designed for endoscopic procedures. It integrates a light source with video capture capabilities to enable real-time fluorescence imaging, enhancing visualization of tissue perfusion and anatomical structures during minimally invasive surgery.

This device is intended for use in hospital operating rooms by surgeons and operates as part of a larger system, including an endoscopic video processor/illuminator, surgical laparoscopes, and a camera head. It is classified as a Class III medical device under FDA regulations and holds FDA_PMA approval (PMA Number: P950042). The system is not described as single-use or reusable in the provided data, nor is MRI safety or sterility explicitly stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pinpoint: A research tool for journalists, PINPOINT - Stryker, PINPOINT Endoscopic Fluorescence Imaging System, Pinpoint Endoscopic Light Source and Video Camera, PINPOINT PC9000 Operator's Manual - Download | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P950042	Class III	Active

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Manufacturer

Manufacturer: Novadaq Technologies Inc
FDA Applicant: Novadaq Technologies, Inc.

Sources (1)

FDA PMA P950042 24 fields · synced Sep 18, 2026