The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Scb / Covidien Forcetriad Interface Module.
| Device ID | K111165 |
| 510k Number | K111165 |
| Device Name: | KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE |
| Classification | Endoscopic Central Control Unit |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Crystal Hagan |
| Correspondent | Crystal Hagan KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-26 |
| Decision Date | 2012-01-06 |
| Summary: | summary |