PMA
P870080: HULKA CLIP FOR TUBAL OCCLUSION
FDA PMA · Laparoscopic contraceptive tubal occlusion device · Richard Wolf Medical Instruments Corp.
Key facts
| PMA number | P870080 |
|---|---|
| Trade name | HULKA CLIP FOR TUBAL OCCLUSION |
| Generic name | Laparoscopic contraceptive tubal occlusion device |
| Applicant | Richard Wolf Medical Instruments Corp. |
| Owner/operator | RICHARD WOLF GMBH |
| Product code | KNH |
| Approval date | Sep 5, 1996 |
| Docket number | 97M-0123 |
| Notice date | Apr 2, 1997 |
| Establishment registration | 1418479 |
| FEI number | 1418479 |
At a glance
- 1–9 Supplements
- Oct 14, 2016 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: