Clinitex Vis-X Aspirating Accessory
510(k) K780852
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780852 | Date3 Nov 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HKP
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4150
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Clinitex Vis-X Aspirating Accessory is a Vitreous Aspiration and Cutting, Battery-Powered Instrument (HKP) designed for ophthalmic procedures. It functions as an adjunct to vitreoretinal surgery, facilitating the aspiration and removal of vitreous humor or other intraocular materials during surgical interventions.
This device is supplied as a reusable instrument and is classified under FDA 510(k) clearance (K780852) with a decision of Substantially Equivalent (SESE). It is intended for use in controlled surgical environments and adheres to regulatory standards for ophthalmic instruments, with no specific sterility or MRI safety constraints noted in the data. Authorized by the FDA under the Ophthalmic Advisory Committee, it remains in compliance with the applicable medical device regulations.