ETHIZIA Hemostatic Patch
by Ethicon Inc.
PMA P240035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP240035 | Date15 Dec 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Ethizia
- Generic name
- Agent, absorbable hemostatic, collagen with polymeric additives
- FDA applicant
- ETHICON, Inc.
- PMA number
- FDA product code
- SGV
- Device class
- Class III
- Regulation
- 21 CFR Part 878.4490
- Advisory committee
- General, Plastic Surgery
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Ethizia Hemostatic Patch is an absorbable hemostatic agent composed of collagen with polymeric additives, classified as a Class III medical device. It is designed to achieve hemostasis in adult patients weighing 25 kg or more during open liver surgery when standard techniques such as suture, ligature, or cautery are ineffective or impractical.
This single-use, sterile patch is intended for use in surgical settings and is approved under FDA PMA (P240035). It is supplied in sterile packaging and must be handled under aseptic conditions. The device adheres to regulatory standards for absorbable hemostatic agents and is categorized under product code SGV, with registration numbers 3023251262, 3017102971, 3014272734, and 3008102042.