The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe.
| Device ID | K944861 |
| 510k Number | K944861 |
| Device Name: | KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551104330 | K944861 | 000 |
| 04048551195390 | K944861 | 000 |
| 04048551207826 | K944861 | 000 |
| 04048551207925 | K944861 | 000 |
| 04048551213728 | K944861 | 000 |
| 04048551218907 | K944861 | 000 |
| 04048551218914 | K944861 | 000 |
| 04048551218921 | K944861 | 000 |
| 04048551218938 | K944861 | 000 |
| 04048551218945 | K944861 | 000 |
| 04048551218952 | K944861 | 000 |
| 04048551218969 | K944861 | 000 |
| 04048551195383 | K944861 | 000 |