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FDA 510(k)

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

K-Number: K152619 · 2016-04-29

ApplicantProsurg, Inc.
Decision Date2016-04-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152619. 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 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Prosurg, Inc.. The 510(k) number is K152619.

When did Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) receive FDA 510(k) clearance?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152619.

Who is the listed applicant for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA 510(k) record lists Prosurg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is GCJ.

Related Clinical Trials

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.

NCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITINGNCT07687628Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal FistulaRECRUITING

Other records listing Prosurg, Inc. 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.

K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaK152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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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