The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Gaab Neuroendoscope And Chavantes-zaamorano Neuroendoscope Sets.
| Device ID | K982837 |
| 510k Number | K982837 |
| Device Name: | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS |
| 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 | 1998-08-12 |
| Decision Date | 1998-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551106068 | K982837 | 000 |
| 04048551094365 | K982837 | 000 |
| 04048551094433 | K982837 | 000 |
| 04048551094457 | K982837 | 000 |
| 04048551094464 | K982837 | 000 |
| 04048551094501 | K982837 | 000 |
| 04048551094525 | K982837 | 000 |
| 04048551094549 | K982837 | 000 |
| 04048551096628 | K982837 | 000 |
| 04048551094334 | K982837 | 000 |
| 04048551093177 | K982837 | 000 |
| 04048551379325 | K982837 | 000 |
| 04048551007617 | K982837 | 000 |
| 04048551091432 | K982837 | 000 |
| 04048551091456 | K982837 | 000 |
| 04048551091463 | K982837 | 000 |
| 04048551091494 | K982837 | 000 |
| 04048551091517 | K982837 | 000 |
| 04048551091609 | K982837 | 000 |
| 04048551103180 | K982837 | 000 |
| 04048551103234 | K982837 | 000 |
| 04048551279663 | K982837 | 000 |
| 04048551103616 | K982837 | 000 |
| 04048551103630 | K982837 | 000 |
| 04048551103654 | K982837 | 000 |
| 04048551103678 | K982837 | 000 |
| 04048551103692 | K982837 | 000 |
| 04048551103715 | K982837 | 000 |
| 04048551103739 | K982837 | 000 |
| 04048551103753 | K982837 | 000 |
| 04048551103593 | K982837 | 000 |
| 04048551103579 | K982837 | 000 |
| 04048551326572 | K982837 | 000 |
| 04048551340394 | K982837 | 000 |
| 04048551405079 | K982837 | 000 |
| 04048551105214 | K982837 | 000 |
| 04048551098349 | K982837 | 000 |
| 04048551098998 | K982837 | 000 |
| 04048551103210 | K982837 | 000 |
| 04048551103555 | K982837 | 000 |
| 04048551103777 | K982837 | 000 |