Cannula, Trocar, Ophthalmic
The Cannula, Trocar, Ophthalmic (product code NGY) is a manual surgical instrument used in ophthalmic procedures, specifically designed as a single-use cannula and trocar set to create access ports in the eye for vitreoretinal surgery, as described in its definition. It is classified as an FDA Class 1 device within the Ophthalmic specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as a permanent implant or life-sustaining device.
Research product code NGY in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NGY
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K012435 | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | Oct 02, 2001 | Substantially Equivalent | Bausch & Lomb, Inc. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.