The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Insulated Grooved, Skiked, Ablator, Fixed Barrel With Grooves, Coagulating Loop, Depth-limiting Loop Electros.
| Device ID | K952574 |
| 510k Number | K952574 |
| Device Name: | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS |
| Classification | Resectoscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-07-20 |