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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551090091 | K944795 | 000 |
| 04048551089873 | K944795 | 000 |
| 04048551089897 | K944795 | 000 |
| 04048551089910 | K944795 | 000 |
| 04048551089934 | K944795 | 000 |
| 04048551089965 | K944795 | 000 |
| 04048551089972 | K944795 | 000 |
| 04048551089996 | K944795 | 000 |
| 04048551090022 | K944795 | 000 |
| 04048551090039 | K944795 | 000 |
| 04048551090053 | K944795 | 000 |
| 04048551090077 | K944795 | 000 |
| 04048551089378 | K944795 | 000 |