K102274 is an FDA 510(k) clearance for the ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT, a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Arvik Enterprises/ Mini Lap Technologies (Shelton, US). The FDA issued a Cleared decision on June 15, 2011, 308 days after receiving the submission on August 11, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K102274 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2010 |
| Decision Date | June 15, 2011 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |