← FDA Medical Device Classifications
Device, Impotence, Mechanical/Hydraulic
FHW · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.3350
Classification
- FDA Product Code
FHW- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 876.3350
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown