Irrigation/Aspiration Kit
by Vxtra Corp. 510(k)
Active
510(k) K830385
Overview
The Irrigation/Aspiration Kit is an ophthalmic device used for irrigation and aspiration procedures during eye surgery. It is classified as a Class II medical device and is designed to facilitate the removal of phacofragments during cataract surgery.
The kit is supplied by Vxtra Corp. and is authorized under FDA 510(k) clearance with number K830385. It is regulated under product code HQC and is intended for use in ophthalmic procedures. The device is not specified as single-use or reusable, and no information regarding MRI safety or sterility is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830385 | Date5 Apr 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vxtra Corp.
Questions
What is the Irrigation/Aspiration Kit used for?
The Irrigation/Aspiration Kit is an ophthalmic device specifically designed for irrigation and aspiration procedures during eye surgery, particularly for facilitating the removal of phacofragments during cataract surgery.
Is the Irrigation/Aspiration Kit single-use or reusable?
The device data does not specify whether the Irrigation/Aspiration Kit is intended for single-use or reusable applications. This information should be confirmed with the manufacturer Vxtra Corp. before clinical use.
What regulatory authorization does the Irrigation/Aspiration Kit have?
The Irrigation/Aspiration Kit is authorized under FDA 510(k) clearance with number K830385, classified as a Class II medical device, and regulated under product code HQC for ophthalmic procedures.
Is the Irrigation/Aspiration Kit supplied sterile?
The device data does not provide information regarding the sterility status of the Irrigation/Aspiration Kit. This detail should be verified directly with Vxtra Corp. as it may impact clinical handling and usage protocols.