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FDA 510(k)

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)

K-Number: K162388 · 2017-02-03

ApplicantCuraseal, Inc.
Decision Date2017-02-03
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is a medical device manufactured by Curaseal, Inc.. It received FDA 510(k) clearance on 2017-02-03 under approval number K162388. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is a medical device that received FDA 510(k) clearance on 2017-02-03. It is manufactured by Curaseal, Inc.. The 510(k) number is K162388.

When was CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) approved by the FDA?

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) received FDA 510(k) clearance on 2017-02-03, under approval number K162388.

What company makes CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is manufactured by Curaseal, Inc..

What is the FDA product code for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)?

The FDA product code for CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF) is FTM.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT05887700 Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING

Related PubMed Literature

PMID: 28988455 Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016. Journal of cardiovascular electrophysiology (2018) PMID: 25499024 Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon. Cardiovascular revascularization medicine : including molecular interventions (2014)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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