The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Calculase Ii.
| Device ID | K140964 |
| 510k Number | K140964 |
| Device Name: | CALCULASE II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 -5017 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 -5017 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-15 |
| Decision Date | 2014-09-04 |
| Summary: | summary |