Vitreous Suction Cutter
by Concept, Inc. 510(k)
Active
510(k) K761353
Overview
The Vitreous Suction Cutter is an ophthalmic instrument designed for vitreous aspiration and cutting. It is a battery-powered device used to remove vitreous matter during ophthalmic procedures.
This device is supplied as a Class 2 instrument with FDA 510(k) clearance K761353, granted on January 5, 1977. It is regulated under product code HKP and is intended for single-use in ophthalmic settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761353 | Date5 Jan 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Viterous Suction Cutter
- 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
Other devices from Concept, Inc.
Questions
What is the Vitreous Suction Cutter used for?
The Vitreous Suction Cutter is designed for vitreous aspiration and cutting during ophthalmic procedures, enabling surgeons to remove vitreous matter from the eye using battery-powered suction and cutting action.
How is the Vitreous Suction Cutter supplied and is it reusable?
The device is supplied as a single-use instrument, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.
What regulatory clearance does the Vitreous Suction Cutter have?
The Vitreous Suction Cutter has FDA 510(k) clearance under number K761353, granted on January 5, 1977, and is classified as a Class 2 medical device under product code HKP.