The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Model 26021c Bipolar Coagulator.
| Device ID | K871745 |
| 510k Number | K871745 |
| Device Name: | MODEL 26021C BIPOLAR COAGULATOR |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Norman Silbertrust |
| Correspondent | Norman Silbertrust KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-07-10 |