The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Gyrus Endourology System: Axipolar Resectoscope Electrode.
| Device ID | K994166 |
| 510k Number | K994166 |
| Device Name: | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff, GB Cf3 0lt |
| Contact | David Kay |
| Correspondent | David Kay GYRUS MEDICAL LTD. FORTRAN RD., ST. MELLONS Cardiff, GB Cf3 0lt |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 1999-12-27 |
| Summary: | summary |