K012579 is an FDA 510(k) clearance for the REPROCESSED PHACO TIPS. This device is classified as a Needle, Phacoemulsification, Reprocessed (Class II - Special Controls, product code NKX).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 8, 2001, 91 days after receiving the submission on August 9, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670. Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K012579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2001 |
| Decision Date | November 08, 2001 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NKX — Needle, Phacoemulsification, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |
| Definition | Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |