Cannula, Trocar, Ophthalmic

NGY · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4350

Classification

FDA Product Code: NGY
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.4350
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 60

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown