Submission Details
| 510(k) Number | K930113 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 402 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
Cleared
Traditional
KIRWAN IRRIGATION/ASPIRATION HANDPIECE
Feb 1994
Decision
402d
Days
Class 1
Risk
About This 510(k) Submission
K930113 is an FDA 510(k) clearance for the KIRWAN IRRIGATION/ASPIRATION HANDPIECE, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Kirwan Surgical Products, Inc. (Rockland, US). The FDA issued a Cleared decision on February 17, 1994, 402 days after receiving the submission on January 11, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.
Device Classification
| Product Code | HMX — Cannula, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4350 |
Manufacturer
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