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FDA 510(k)

System 83 Revolve Endoscope Washer/Disinfector

K-Number: K241168 · 2024-12-19

ApplicantWassenburg Medical, Inc.
Decision Date2024-12-19
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

System 83 Revolve Endoscope Washer/Disinfector is a medical device manufactured by Wassenburg Medical, Inc.. It received FDA 510(k) clearance on 2024-12-19 under approval number K241168. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the System 83 Revolve Endoscope Washer/Disinfector?

System 83 Revolve Endoscope Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Wassenburg Medical, Inc.. The 510(k) number is K241168.

When was System 83 Revolve Endoscope Washer/Disinfector approved by the FDA?

System 83 Revolve Endoscope Washer/Disinfector received FDA 510(k) clearance on 2024-12-19, under approval number K241168.

What company makes System 83 Revolve Endoscope Washer/Disinfector?

System 83 Revolve Endoscope Washer/Disinfector is manufactured by Wassenburg Medical, Inc..

What is the FDA product code for System 83 Revolve Endoscope Washer/Disinfector?

The FDA product code for System 83 Revolve Endoscope Washer/Disinfector is FEB.

Related Clinical Trials

NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING

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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.

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