Anal Fistula Closure Device

QML · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4835

Classification

FDA Product Code: QML
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4835
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown