K012435 is an FDA 510(k) clearance for the ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626. This device is classified as a Cannula, Trocar, Ophthalmic (Class I - General Controls, product code NGY).
Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 2, 2001, 63 days after receiving the submission on July 31, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350. 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) Number | K012435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2001 |
| Decision Date | October 02, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NGY - Cannula, Trocar, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |
| 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. |