The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Distending Diverticuloscope.
| Device ID | K953596 |
| 510k Number | K953596 |
| Device Name: | DISTENDING DIVERTICULOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Lydia N Telep |
| Correspondent | Lydia N Telep KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-01 |
| Decision Date | 1995-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551053584 | K953596 | 000 |
| 04048551053577 | K953596 | 000 |
| 04048551053317 | K953596 | 000 |
| 04048551053300 | K953596 | 000 |