← FDA Medical Device Classifications
Eustachian Tube Balloon Dilation Device
PNZ · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.4180
Classification
- FDA Product Code
PNZ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 874.4180
- Review panel
- EN
- Medical specialty
- Ear, Nose, Throat
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 17
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown