FDA product code NGY: Cannula, Trocar, Ophthalmic
NGY is the FDA product code for cannula, trocar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NGY. The average 510(k) review took 63 days (median 63). FDA has posted 11 recalls for NGY devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Trocar, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NGY clearance
Top NGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bausch & Lomb, Inc. | 1 | 2001-10-02 |
Most recent NGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012435 | Bausch & Lomb, Inc. | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | 2001-10-02 | 63 |
Recalls for NGY devices
11 product recalls in 7 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NGY?
NGY is the FDA product code for cannula, trocar, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is NGY?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NGY?
Across 1 cleared submissions the average was 63 days from receipt to decision (median 63).
Which companies have the most NGY clearances?
Bausch & Lomb, Inc. (1).
Have NGY devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NGY
- Run a recall and safety report across every NGY manufacturer
- Watch product code NGY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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