The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Monopolar Coagulating Electrodes/ Karl Storz Monopolar Coagulating Needle Electrodes.
| Device ID | K972497 |
| 510k Number | K972497 |
| Device Name: | KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marlena A Piercy |
| Correspondent | Marlena A Piercy KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551402436 | K972497 | 000 |
| 04048551225899 | K972497 | 000 |