K083428 is an FDA 510(k) clearance for the F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY. This device is classified as a Unit, Cautery, Thermal, Battery-powered (Class II - Special Controls, product code HQP).
Submitted by Fiab Spa (Firenze, IT). The FDA issued a Cleared decision on September 1, 2009, 286 days after receiving the submission on November 19, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K083428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2008 |
| Decision Date | September 01, 2009 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQP - Unit, Cautery, Thermal, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |