K972749 is an FDA 510(k) clearance for the PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S). This device is classified as a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II - Special Controls, product code HQR).
Submitted by C.M. Chance , Ltd. (Southampton, US). The FDA issued a Cleared decision on March 13, 1998, 233 days after receiving the submission on July 23, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4100.
| 510(k) Number | K972749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1997 |
| Decision Date | March 13, 1998 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQR — Apparatus, Cautery, Radiofrequency, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4100 |