ERBEJET 2 System
510(k) K231023
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231023 | Date15 Jun 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K231023 decided 15 Jun 2023 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- FQH
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5475
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The ERBEJET 2 System is a Jet Lavage Device designed for precise and selective tissue dissection and hydrodissection. It delivers controlled fluid jets to minimize trauma to delicate structures such as vessels, nerves, and ducts, facilitating targeted separation of tissues during surgical procedures.
This system is intended for use in endoscopic and surgical settings, where it enables selective expansion of the submucosal tissue plane through tissue-selective hydrodissection. Supplied as a reusable device, it requires proper sterilization and maintenance as per manufacturer guidelines. Authorized under FDA 510(k) and MDR, the ERBEJET 2 System adheres to regulatory standards for medical devices in general hospital applications.