← FDA Medical Device Classifications
Colonic Irrigation System, General Well Being
NUB · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.5220
Classification
- FDA Product Code
NUB- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 876.5220
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown