Comatryx OTC— 510(k) K232758

Name: FDA 510(k) clearance K232758
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Substantially Equivalent

Strukmyer Medical, LLC

FDA 510(k) clearance K232758 for Comatryx OTC, Substantially Equivalent on 2023-12-01. Applicant: Strukmyer Medical, LLC. Device class: Unclassified.

Clearance details

Applicant: Strukmyer Medical, LLC
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2023-09-08
Decision date: 2023-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesquite, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.