Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Endoscope Valve Sets

K-Number: K220884 · 2023-01-17

Decision Date2023-01-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Valve Sets is a medical device manufactured by Sml Med-Tech Solutions Limited. It received FDA 510(k) clearance on 2023-01-17 under approval number K220884. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscope Valve Sets?

Disposable Endoscope Valve Sets is a medical device that received FDA 510(k) clearance on 2023-01-17. It is manufactured by Sml Med-Tech Solutions Limited. The 510(k) number is K220884.

When was Disposable Endoscope Valve Sets approved by the FDA?

Disposable Endoscope Valve Sets received FDA 510(k) clearance on 2023-01-17, under approval number K220884.

What company makes Disposable Endoscope Valve Sets?

Disposable Endoscope Valve Sets is manufactured by Sml Med-Tech Solutions Limited.

What is the FDA product code for Disposable Endoscope Valve Sets?

The FDA product code for Disposable Endoscope Valve Sets is ODC.

Related Devices (Code: ODC)

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.