The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Bipolar Coagulating Electrodes.
| Device ID | K001630 |
| 510k Number | K001630 |
| Device Name: | KSEA BIPOLAR COAGULATING ELECTRODES |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-26 |
| Decision Date | 2000-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551115220 | K001630 | 000 |
| 04048551115206 | K001630 | 000 |
| 04048551097489 | K001630 | 000 |
| 04048551096765 | K001630 | 000 |
| 04048551256770 | K001630 | 000 |