The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Gyrus Endourology System: Axipolar Resectoscope Loop Electrode.
| Device ID | K001270 |
| 510k Number | K001270 |
| Device Name: | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE |
| Classification | Resectoscope |
| 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 | FJL |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FDC |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-20 |
| Decision Date | 2000-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009240 | K001270 | 000 |
| 00821925009233 | K001270 | 000 |