K121441 is an FDA 510(k) clearance for the CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP). This device is classified as a Unit, Cautery, Thermal, Battery-powered (Class II - Special Controls, product code HQP).
Submitted by Bovie Medical Corporation (Clearwater, US). The FDA issued a Cleared decision on July 20, 2012, 66 days after receiving the submission on May 15, 2012.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K121441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2012 |
| Decision Date | July 20, 2012 |
| Days to Decision | 66 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 |