K220891 is an FDA 510(k) clearance for the Kahook Dual Blade Glide (KDB Glide). This device is classified as a Knife, Intraocular Pressure Lowering (Class II - Special Controls, product code QUQ).
Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 17, 2024, 781 days after receiving the submission on March 28, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 878.4400. A Knife Intended For Cutting Of Trabecular Meshwork To Reduce Intraocular Pressure In Glaucoma.
| 510(k) Number | K220891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2022 |
| Decision Date | May 17, 2024 |
| Days to Decision | 781 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | QUQ - Knife, Intraocular Pressure Lowering |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | A Knife Intended For Cutting Of Trabecular Meshwork To Reduce Intraocular Pressure In Glaucoma |