The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Bipolar Electrode.
| Device ID | K122983 |
| 510k Number | K122983 |
| Device Name: | KSEA BIPOLAR ELECTRODE |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-26 |
| Decision Date | 2013-06-26 |
| Summary: | summary |