510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QMLClass II

Anal Fistula Closure Device

21 CFR 878.4835 / General, Plastic Surgery
FDA source (opens on fda.gov)

QML is the FDA product code for Anal Fistula Closure Device, a class II device type, regulated under 21 CFR 878.4835. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QML
Device name
Anal Fistula Closure Device
FDA 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.
Regulation
21 CFR 878.4835
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QML

By decision year
1 clearance under product code QML with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QML by decision year
YearClearances
20241

Applicants with the most clearances

Product code QML
Applicants holding the most 510(k) clearances under product code QML
ApplicantClearances
Signum Surgical Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code