The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Unipolar Ball, Needle, Loop Electrodes.
| Device ID | K944795 |
| 510k Number | K944795 |
| Device Name: | KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Judith K Murphy |
| Correspondent | Judith K Murphy KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-28 |
| Decision Date | 1994-12-21 |