← FDA Medical Device Classifications
Esophageal Dilator With Balloon And Electrode Sensors
PIE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5980
Classification
- FDA Product Code
PIE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 876.5980
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To dilate esophageal strictures with a dilating balloon and electrode sensors.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown