CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM— 510(k) K132463

Substantially Equivalent

Cianna Medical, Inc.

FDA 510(k) clearance K132463 for CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM, Substantially Equivalent on 2013-12-03. Applicant: Cianna Medical, Inc..

Clearance details

Applicant: Cianna Medical, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2013-08-07
Decision date: 2013-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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.