← FDA Medical Device Classifications
Administrations Sets With Neuraxial Connectors
PWH · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440
Classification
- FDA Product Code
PWH- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.5440
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Market data
- Cleared 510(k) submissions
- 4
- Registered establishments
- 7
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown