K000893 is an FDA 510(k) clearance for the AC POWERED THERMAL CAUTERY UNIT. This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).
Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on June 14, 2000, 86 days after receiving the submission on March 20, 2000.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K000893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2000 |
| Decision Date | June 14, 2000 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQO — Unit, Cautery, Thermal, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |