Hemorrhoid Prevention Pressure Wedge

OOA · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5200

Classification

FDA Product Code: OOA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.5200
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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