NGY — Cannula, Trocar, Ophthalmic Class I
FDA product code NGY covers "Cannula, Trocar, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NGY
- Device Class
- Class I
- Regulation Number
- 886.4350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K012435 | bausch and lomb | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | October 2, 2001 |