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FDA 510(k)

HD-500 Video Endoscope System

K-Number: K173921 · 2018-09-05

Decision Date2018-09-05
Product CodeNWB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD-500 Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K173921. The device is classified under product code NWB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD-500 Video Endoscope System?

HD-500 Video Endoscope System is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K173921.

When did HD-500 Video Endoscope System receive FDA 510(k) clearance?

HD-500 Video Endoscope System received FDA 510(k) clearance on 2018-09-05, under 510(k) number K173921.

Who is the listed applicant for HD-500 Video Endoscope System?

The FDA 510(k) record lists Sonoscape Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD-500 Video Endoscope System?

The FDA product code for HD-500 Video Endoscope System is NWB.

Other records listing Sonoscape Medical Corp. 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.

View all 22 devices →

Related Devices (Code: NWB)

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.

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.