The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Video Gastroscopes.
| Device ID | K060907 |
| 510k Number | K060907 |
| Device Name: | KARL STORZ VIDEO GASTROSCOPES |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE Culver City, CA 90230 |
| Contact | Paul S Lee |
| Correspondent | Paul S Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE Culver City, CA 90230 |
| Product Code | FDS |
| Subsequent Product Code | FWF |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551220559 | K060907 | 000 |
| 04048551003633 | K060907 | 000 |
| 04048551227541 | K060907 | 000 |
| 04048551227589 | K060907 | 000 |
| 04048551227602 | K060907 | 000 |
| 04048551227626 | K060907 | 000 |
| 04048551227664 | K060907 | 000 |
| 04048551227749 | K060907 | 000 |
| 04048551227763 | K060907 | 000 |
| 04048551227787 | K060907 | 000 |
| 04048551390221 | K060907 | 000 |
| 04048551390436 | K060907 | 000 |
| 04048551379479 | K060907 | 000 |
| 04048551408919 | K060907 | 000 |
| 04048551409824 | K060907 | 000 |
| 04048551003619 | K060907 | 000 |