Product code LMG
- Device name
- Agent, Absorbable Hemostatic, Non-Collagen Based
- Medical specialty
- General, Plastic Surgery
- Device class
- 3
- Regulation number
- 878.4490
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P050038S043 | Arista™ AH | Davol, Inc. | 2026-04-29 |
| N12159S128 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2026-01-15 |
| N12159S127 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2025-12-12 |
| N12159S122 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2025-11-04 |
| N12159S126 | SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. | ETHICON, Inc. | 2025-10-09 |
| N12159S125 | SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder | ETHICON, Inc. | 2025-09-24 |
| N12159S123 | SURGICEL BRAND ABSORBABLE HEMOSTAT | ETHICON, Inc. | 2025-09-09 |
| N12159S124 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2025-09-04 |
| P210036S005 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | 2025-04-25 |
| N12159S102 | SURGICEL® Absorbable Hemostats and SURGICEL® POWDER Absorbable Hemostatic Powder | ETHICON, Inc. | 2025-03-21 |
| N12159S120 | SURGICEL SNoW Absorbable Hemostats; SURGICEL FIBRILLAR Absorbable Hemostats | ETHICON, Inc. | 2025-03-07 |
| N12159S112 | SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR | ETHICON, Inc. | 2025-03-05 |
| N12159S119 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2025-01-30 |
| P210036S002 | PerClot Polysaccharide Hemostatic System | Baxter Healthcare Corporation | 2024-12-20 |
| N12159S118 | SURGICEL Absorbable Hemostats | ETHICON, Inc. | 2024-12-19 |
| N12159S116 | SURGICEL Powder Absorbable Hemostats | ETHICON, Inc. | 2024-12-13 |
| N12159S117 | SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator) | ETHICON, Inc. | 2024-12-05 |
| P050038S042 | Arista AH | Davol, Inc. | 2024-11-04 |
| N12159S115 | SURGICEL® Absorbable Hemostats (SURGICEL® SNOW™) | ETHICON, Inc. | 2024-08-28 |
| N12159S114 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2024-08-27 |
| P210036S004 | PerClot Polysaccharide Hemostatic System | Baxter Healthcare Corporation | 2024-07-18 |
| N12159S113 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2024-06-13 |
| N12159S110 | SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® FIBRILLAR™, SURGICEL® SNOW™ | ETHICON, Inc. | 2024-05-16 |
| N12159S111 | SURGICEL® Absorbable Hemostats (SURGICEL POWDER™) | ETHICON, Inc. | 2024-05-14 |
| P210036S001 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | 2024-05-08 |
| N12159S109 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2024-05-01 |
| N12159S108 | SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) | ETHICON, Inc. | 2023-12-14 |
| N12159S106 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2023-11-14 |
| N12159S107 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2023-11-01 |
| N12159S105 | SURGICEL® Absorbable Hemostats | ETHICON, Inc. | 2023-09-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10705031468085 | SURGICEL NU-KNIT | Ethicon Sàrl | 2023-07-28 |
| 10705031468139 | SURGICEL | Ethicon Sàrl | 2023-05-15 |
| 10705031468122 | SURGICEL | Ethicon Sàrl | 2023-05-15 |
| 10705031468115 | SURGICEL | Ethicon Sàrl | 2023-05-15 |
| 10705031468108 | SURGICEL | Ethicon Sàrl | 2023-05-15 |
| 10705031468092 | SURGICEL NU-KNIT | Ethicon Sàrl | 2023-05-15 |
| 10705031237513 | SURGICEL | ETHICON, LLC | 2019-05-13 |
| 10705031237506 | ETHICON | ETHICON, LLC | 2017-08-31 |
| 10705031002968 | SURGICEL NU-KNIT | Ethicon Sàrl | 2016-10-19 |
| 10705031002951 | SURGICEL NU-KNIT | Ethicon Sàrl | 2016-10-19 |
| 10705031063617 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031002999 | SURGICEL NU-KNIT | Ethicon Sàrl | 2014-09-20 |
| 10705031003019 | SURGICEL | Ethicon Sàrl | 2014-09-20 |
| 10705031003026 | SURGICEL | Ethicon Sàrl | 2014-09-20 |
| 10705031003033 | SURGICEL | Ethicon Sàrl | 2014-09-20 |
| 10705031003064 | SURGICEL | Ethicon Sàrl | 2014-09-20 |
| 10705031003118 | SURGICEL FIBRILLAR | Ethicon Sàrl | 2014-09-20 |
| 10705031003125 | SURGICEL FIBRILLAR | Ethicon Sàrl | 2014-09-20 |
| 10705031063631 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031063624 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031003132 | SURGICEL FIBRILLAR | Ethicon Sàrl | 2014-09-20 |
| 10705031063600 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031063594 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031063587 | SURGICEL SNoW | ETHICON, LLC | 2014-09-20 |
| 10705031005372 | TABOTAMP FIBRILLAR | ETHICON, LLC | 2014-09-20 |
| 10705031005365 | SURGICEL FIBRILLAR | ETHICON, LLC | 2014-09-20 |
| 10705031005358 | SURGICEL FIBRILLAR | ETHICON, LLC | 2014-09-20 |
| 10705031005211 | SURGICEL FIBRILLAR | ETHICON, LLC | 2014-09-20 |
| 10705031005204 | SURGICEL FIBRILLAR | ETHICON, LLC | 2014-09-20 |
| 10705031005198 | SURGICEL FIBRILLAR | ETHICON, LLC | 2014-09-20 |