K022306 is an FDA 510(k) clearance for the AART SILICONE TUBING. This device is classified as a Accessories, Catheter (Class I — General Controls, product code KGZ).
Submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on October 10, 2002, 86 days after receiving the submission on July 16, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K022306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2002 |
| Decision Date | October 10, 2002 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGZ — Accessories, Catheter |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |