FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Laparoscopic Contraceptive Tubal Occlusion Device
PMA: P870080
·
Supplement: S002
·
Decision Oct 14, 2016
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
- Supplement Number
- S002
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 14, 2016
- Date Received
- August 22, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.
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 |