K061194 is an FDA 510(k) clearance for the PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on August 24, 2006, 118 days after receiving the submission on April 28, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K061194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2006 |
| Decision Date | August 24, 2006 |
| Days to Decision | 118 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG — Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |