510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QWWClass II

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

21 CFR 876.5021 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QWW is the FDA product code for Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction., a class II device type, regulated under 21 CFR 876.5021. FDA's definition for this code reads: "A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWW
Device name
Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
FDA definition
A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
Regulation
21 CFR 876.5021
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QWW

By decision year
1 clearance under product code QWW with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWW by decision year
YearClearances
20231

Applicants with the most clearances

Product code QWW
Applicants holding the most 510(k) clearances under product code QWW
ApplicantClearances
Futura Medical Developments Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code