The following data is part of a premarket notification filed by Gyrus Medical Ltd. with the FDA for Gyrus Endourology System.
| Device ID | K990628 |
| 510k Number | K990628 |
| Device Name: | GYRUS ENDOUROLOGY SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-25 |
| Decision Date | 1999-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009226 | K990628 | 000 |
| 00821925009097 | K990628 | 000 |
| 00821925009080 | K990628 | 000 |
| 00821925009073 | K990628 | 000 |
| 00821925009066 | K990628 | 000 |
| 00821925009059 | K990628 | 000 |
| 00821925009042 | K990628 | 000 |
| 00821925009035 | K990628 | 000 |
| 00821925009028 | K990628 | 000 |
| 00821925009011 | K990628 | 000 |
| 00821925009110 | K990628 | 000 |
| 00821925009134 | K990628 | 000 |
| 00821925009868 | K990628 | 000 |
| 00821925009264 | K990628 | 000 |
| 00821925009257 | K990628 | 000 |
| 00821925009196 | K990628 | 000 |
| 00821925009189 | K990628 | 000 |
| 00821925009172 | K990628 | 000 |
| 00821925009165 | K990628 | 000 |
| 00821925009158 | K990628 | 000 |
| 00821925009141 | K990628 | 000 |
| 00821925010499 | K990628 | 000 |