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FDA 510(k)

Ultrasonic Gastrovideoscope

K-Number: K231813 · 2024-03-08

Decision Date2024-03-08
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Gastrovideoscope 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 2024-03-08 under 510(k) number K231813. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Gastrovideoscope?

Ultrasonic Gastrovideoscope is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K231813.

When did Ultrasonic Gastrovideoscope receive FDA 510(k) clearance?

Ultrasonic Gastrovideoscope received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231813.

Who is the listed applicant for Ultrasonic Gastrovideoscope?

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 Ultrasonic Gastrovideoscope?

The FDA product code for Ultrasonic Gastrovideoscope is ODG.

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: ODG)

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.