PMA
N12159: SURGICEL BRAND ABSORBABLE HEMOSTAT
FDA PMA · Agent, absorbable hemostatic, non-collagen based · ETHICON, Inc.
Key facts
| PMA number | N12159 |
|---|---|
| Trade name | SURGICEL BRAND ABSORBABLE HEMOSTAT |
| Generic name | Agent, absorbable hemostatic, non-collagen based |
| Applicant | ETHICON, Inc. |
| Owner/operator | ETHICON INC. |
| Product code | LMG |
| Approval date | Oct 14, 1960 |
| Establishment registration | 2210968 |
| FEI number | 2210968 |
At a glance
- 100–999 Supplements
- Jul 28, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: