← FDA Medical Device Classifications
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
PFJ · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.4260
Classification
- FDA Product Code
PFJ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 884.4260
- Review panel
- OB
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Mechanical dilation of the cervical canal for labor.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown