Ethicon
Absorbable Hemostatic Powder, Oxidized Regenerated Cellulose
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Huan QIU LI Kang Biotech Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | LMG |
| Device type | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Device class | Class 3 |
| Regulation | 21 CFR 878.4490 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | N12159 |
| Record published | 2017-08-31 |
| Record revised | 2026-04-07 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at controlled room temperature; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3013SP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgicel | Ethicon Sàrl | 8 |
| Surgicel NU-Knit | Ethicon Sàrl | 6 |
| Surgicel SNoW | Ethicon, Inc. | 6 |
| Arista | Davol Inc. | 6 |
| Surgicel Fibrillar | Ethicon, Inc. | 5 |
| PerClot | Baxter Healthcare Corporation | 5 |
| Emergency Medical Products | Emergency Medical Products, Inc. | 3 |
| Veriset | Covidien LP | 3 |
| Surgicel Fibrillar | Ethicon Sàrl | 3 |
| Surgicel | Ethicon, Inc. | 1 |
| Tabotamp Fibrillar | Ethicon, Inc. | 1 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-06-11 | Class II | Process control | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. | 450,793 units (65,950 US, 384,843 OUS) |
| 2024-06-11 | Class II | Process control | Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. | 39,010 units (All US) |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210036 | 2023-05-19 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation |
| N12159 | 2023-04-04 | SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) | Ethicon, Inc. |
| P050038 | 2012-03-23 | ARISTA AH ABSORBABLE HEMOSTAT | Davol Inc. |
| N5798 | 1991-02-08 | OXYCELL | Bd Becton Dickinson Vacutainer Systems Preanalytic |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.