BioZorb SP Marker— 510(k) K192371

Name: FDA 510(k) clearance K192371
Creator: U.S. Food and Drug Administration
Published: 2019-09-26

Substantially Equivalent

Focal Therapeutics

FDA 510(k) clearance K192371 for BioZorb SP Marker, Substantially Equivalent on 2019-09-26. Applicant: Focal Therapeutics. Device class: 2.

Clearance details

Applicant: Focal Therapeutics
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2019-08-30
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K143484 — BioZorb Marker2015-06-29
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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.