CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)— 510(k) K162388

Name: FDA 510(k) clearance K162388
Creator: U.S. Food and Drug Administration
Published: 2017-02-03

Substantially Equivalent

Curaseal, Inc.

FDA 510(k) clearance K162388 for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF), Substantially Equivalent on 2017-02-03. Applicant: Curaseal, Inc.. Device class: 2.

Clearance details

Applicant: Curaseal, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2016-08-25
Decision date: 2017-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.