SOFTXIL— 510(k) K171851

Name: FDA 510(k) clearance K171851
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Substantially Equivalent

Bistool

FDA 510(k) clearance K171851 for SOFTXIL, Substantially Equivalent on 2018-03-16. Applicant: Bistool. Device class: 2.

Clearance details

Applicant: Bistool
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2017-06-21
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.