The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Ksea Vaporization Electrodes.
| Device ID | K961702 |
| 510k Number | K961702 |
| Device Name: | KSEA VAPORIZATION ELECTRODES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-02 |
| Decision Date | 1996-08-29 |
| Summary: | summary |