DeviceClearance

Product code NGY— Ophthalmic

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

Classification name
Cannula, Trocar, Ophthalmic
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.”

— U.S. Food and Drug Administration, device classification record for product code NGY under 21 CFR 886.4350, via openFDA

Market context for product code NGY

FDA has cleared 1 device under product code NGY, all in 2001, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NGY

Recent clearances under product code NGY

Data sourced from openFDA. This site is unofficial and independent of the FDA.