PatCom Distal Chip Endoscope— 510(k) K222587

Substantially Equivalent

H&A Mui Enterprises, Inc.

FDA 510(k) clearance K222587 for PatCom Distal Chip Endoscope, Substantially Equivalent on 2023-07-28. Applicant: H&A Mui Enterprises, Inc..

Clearance details

Applicant: H&A Mui Enterprises, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2022-08-26
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.