K102325 is an FDA 510(k) clearance for the IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD). This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Covidien, LLC, Formerly Registered AS Tyco Healthca (North Haven, US). The FDA issued a Cleared decision on October 13, 2010, 57 days after receiving the submission on August 17, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K102325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2010 |
| Decision Date | October 13, 2010 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |