SURGICEL® Absorbable Hemostats
FDA premarket approval N12159/S130 · decided 2026-06-25
Approval details
- PMA number
- N12159
- Supplement
- S130
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGICEL® Absorbable Hemostats
- Generic name
- Agent, absorbable hemostatic, non-collagen based
- Applicant
- ETHICON, Inc.
- Date received
- 2026-06-03
- Decision date
- 2026-06-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LMG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- equipment upgrades intended to enhance the automation process of the approved automated packer and to address components that have become obsolete
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.