The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Neuroendoscopes And Accessories.
| Device ID | K021050 |
| 510k Number | K021050 |
| Device Name: | KSEA NEUROENDOSCOPES AND ACCESSORIES |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 2002-04-01 |
| Decision Date | 2002-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551288825 | K021050 | 000 |
| 04048551097724 | K021050 | 000 |
| 04048551097694 | K021050 | 000 |
| 04048551007891 | K021050 | 000 |
| 04048551007877 | K021050 | 000 |
| 04048551007853 | K021050 | 000 |
| 04048551007839 | K021050 | 000 |
| 04048551106556 | K021050 | 000 |
| 04048551106549 | K021050 | 000 |
| 04048551106501 | K021050 | 000 |
| 04048551106495 | K021050 | 000 |
| 04048551106488 | K021050 | 000 |
| 04048551097748 | K021050 | 000 |
| 04048551097823 | K021050 | 000 |
| 04048551097861 | K021050 | 000 |
| 04048551288801 | K021050 | 000 |
| 04048551288795 | K021050 | 000 |
| 04048551288788 | K021050 | 000 |
| 04048551191439 | K021050 | 000 |
| 04048551097953 | K021050 | 000 |
| 04048551097762 | K021050 | 000 |
| 04048551098325 | K021050 | 000 |
| 04048551098240 | K021050 | 000 |
| 04048551097977 | K021050 | 000 |
| 04048551097922 | K021050 | 000 |
| 04048551097908 | K021050 | 000 |
| 04048551271476 | K021050 | 000 |