The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Instruments For Bipolar Coagulation.
| Device ID | K936036 |
| 510k Number | K936036 |
| Device Name: | KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Paul L Sumner |
| Correspondent | Paul L Sumner KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-17 |
| Decision Date | 1994-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551176719 | K936036 | 000 |
| 04048551104460 | K936036 | 000 |
| 04048551104439 | K936036 | 000 |
| 04048551104422 | K936036 | 000 |
| 04048551103326 | K936036 | 000 |
| 04048551256268 | K936036 | 000 |
| 04048551172186 | K936036 | 000 |
| 04048551172179 | K936036 | 000 |