FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Laparoscopic Contraceptive Tubal Occlusion Device
PMA: P870080
·
Decision Sep 5, 1996
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Laparoscopic Contraceptive Tubal Occlusion Device
- Trade Name
- HULKA CLIP FOR TUBAL OCCLUSION
- PMA Number
- P870080
- Device Class
- FDA Class 3
- Product Code
- KNH
- Generic Name
- Laparoscopic contraceptive tubal occlusion device
- Regulation Number
- 884.5380
- Medical Specialty
- Obstetrics/Gynecology
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 5, 1996
- Date Received
- December 30, 1987
- Expedited Review
- N
- Docket Number
- 97M-0123
Advisory Committee Statement
APPROVAL FOR THE HULKA CLIP TUBAL OCCLUSION DEVICE AND APPLICATOR SYSTEMS
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNH | Laparoscopic Contraceptive Tubal Occlusion Device | FDA class 3 | Obstetrics/Gynecology |