FDA 510(k)

PatCom Distal Chip Endoscope

K-Number: K222587 · 2023-07-28

Decision Date2023-07-28

Product CodeEOB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PatCom Distal Chip Endoscope is a medical device manufactured by H&A Mui Enterprises, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K222587. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PatCom Distal Chip Endoscope?

PatCom Distal Chip Endoscope is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by H&A Mui Enterprises, Inc.. The 510(k) number is K222587.

When was PatCom Distal Chip Endoscope approved by the FDA?

PatCom Distal Chip Endoscope received FDA 510(k) clearance on 2023-07-28, under approval number K222587.

What company makes PatCom Distal Chip Endoscope?

PatCom Distal Chip Endoscope is manufactured by H&A Mui Enterprises, Inc..

What is the FDA product code for PatCom Distal Chip Endoscope?

The FDA product code for PatCom Distal Chip Endoscope is EOB.

Other Devices by H&A Mui Enterprises, Inc.

K192691PatCom Single-Use Introducer

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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.