The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Navigationpanel Unit (npu) System.
| Device ID | K122096 |
| 510k Number | K122096 |
| Device Name: | KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551271087 | K122096 | 000 |
| 04048551009888 | K122096 | 000 |
| 04048551325988 | K122096 | 000 |
| 04048551277577 | K122096 | 000 |
| 04048551160992 | K122096 | 000 |