The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Irrigation And Suction System Handpiece And Accessories.
| Device ID | K935785 |
| 510k Number | K935785 |
| Device Name: | KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Susie S Chen |
| Correspondent | Susie S Chen KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1994-05-11 |