510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NGYClass I

Cannula, Trocar, Ophthalmic

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

NGY is the FDA product code for Cannula, Trocar, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 11 recalls.

Classification record

Product code
NGY
Device name
Cannula, Trocar, Ophthalmic
FDA 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.
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
11

Clearances, product code NGY

By decision year
1 clearance under product code NGY with a decision year between 2001 and 2001, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NGY by decision year
YearClearances
20011

Applicants with the most clearances

Product code NGY
Applicants holding the most 510(k) clearances under product code NGY
ApplicantClearances
Bausch & Lomb Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order