K955119 is an FDA 510(k) clearance for the SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on January 18, 1996, 70 days after receiving the submission on November 9, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K955119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1995 |
| Decision Date | January 18, 1996 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |