FDA product code · Ophthalmic

Cannula, Trocar, Ophthalmic

Name: FDA decisions, review times, recalls and adverse event reports for product code NGY
Creator: 510(k) Report

NGYClass I21 CFR 886.4350510(k) exempt1 decision since 20016 recalls

FDA lists NGY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2001. 6 recalls name this code, 0 of them Class I.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of NGY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NGY

FDA has decided no NGY device since 2007.

Median 510(k) review, days · NGY

Too few NGY 510(k)s in any year since 2007 to give a median.

Recalls per year · NGY

1in 2025

2007high 2 (2009) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGY

20in 2025

2007high 64 (2016) · low 0 (2008)2025

MAUDE reports naming product code NGY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	1
2008	—	0	0
2009	—	2	0
2010	—	0	0
2011	—	0	4
2012	—	0	1
2013	—	0	0
2014	—	0	0
2015	—	0	16
2016	—	0	64
2017	—	0	46
2018	—	0	25
2019	—	0	15
2020	—	2	9
2021	—	0	7
2022	—	0	10
2023	—	0	32
2024	—	0	14
2025	—	1	20
2026	—	0	—

FIG. 1 — NGY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NGY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 886.4350.

HMZ Trabeculotome HNK Probe, Trabeculotomy HNY Cystotome PZG Surgical Eye Tray HOB Clamp, Muscle, Ophthalmic HNQ Hook, Ophthalmic HOD Clamp, Eyelid, Ophthalmic HNN Knife, Ophthalmic HOE Caliper, Ophthalmic HNJ Punch, Corneo-Scleral HNM Needle, Ophthalmic Suturing HOC Clip, Iris Retractor

Cannula, Trocar, Ophthalmic

What has FDA decided in NGY lately?

What has been recalled in NGY lately?

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