Single-Use Internal Condom

MBU · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5340

Classification

FDA Product Code: MBU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.5340
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 4

Source

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