The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Video Lower G.i. Endoscope System.
| Device ID | K063585 |
| 510k Number | K063585 |
| Device Name: | KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Susie Chen |
| Correspondent | Susie Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-01 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551323120 | K063585 | 000 |
| 04048551054888 | K063585 | 000 |
| 04048551006368 | K063585 | 000 |
| 04048551006351 | K063585 | 000 |
| 04048551006344 | K063585 | 000 |
| 04048551054871 | K063585 | 000 |
| 04048551390443 | K063585 | 000 |
| 04048551228081 | K063585 | 000 |
| 04048551006320 | K063585 | 000 |
| 04048551057193 | K063585 | 000 |
| 04048551057230 | K063585 | 000 |
| 04048551322963 | K063585 | 000 |
| 04048551322949 | K063585 | 000 |
| 04048551322550 | K063585 | 000 |
| 04048551322543 | K063585 | 000 |
| 04048551322536 | K063585 | 000 |
| 04048551312926 | K063585 | 000 |
| 04048551312865 | K063585 | 000 |
| 04048551057254 | K063585 | 000 |
| 04048551312896 | K063585 | 000 |