Pad, Menstrual, Reusable

NUQ · Class I — Low Risk (general controls) · Obstetrics/Gynecology · 21 CFR 884.5435

Classification

FDA Product Code: NUQ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 884.5435
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A reusable, unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 79

Source

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