← FDA Medical Device Classifications
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
PNU · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5210
Classification
- FDA Product Code
PNU- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 884.5210
- Review panel
- OB
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown