K981116 is an FDA 510(k) clearance for the SOVEREIGN CATARACT EXTRACTION SYSTEM. This device is classified as a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG).
Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on May 19, 1998, 53 days after receiving the submission on March 27, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4360.
| 510(k) Number | K981116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1998 |
| Decision Date | May 19, 1998 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYG — Device, Irrigation, Ocular Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4360 |