K153472 is an FDA 510(k) clearance for the Quiver Laparoscopic Extendable, a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Itl Corporation Pty, Ltd. (Chelsea Heights, Vic, AU). The FDA issued a Cleared decision on June 23, 2016, 204 days after receiving the submission on December 2, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K153472 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2015 |
| Decision Date | June 23, 2016 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HAM — Apparatus, Electrosurgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |