K233653 is an FDA 510(k) clearance for the Midfield Light Pipe, 23ga (3269.M06-00). This device is classified as a Endoilluminator (Class II - Special Controls, product code MPA).
Submitted by Peregrine Surgical, LLC (New Britain, US). The FDA issued a Cleared decision on August 5, 2024, 265 days after receiving the submission on November 14, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K233653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2023 |
| Decision Date | August 05, 2024 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MPA - Endoilluminator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |