K994019 is an FDA 510(k) clearance for the CAUTERY GRASPER/DISSECTOR. This device is classified as a Unit, Cautery, Thermal, Battery-powered (Class II - Special Controls, product code HQP).
Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on January 20, 2000, 55 days after receiving the submission on November 26, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K994019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1999 |
| Decision Date | January 20, 2000 |
| Days to Decision | 55 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 |