The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Grasping Forceps, Biopsy Forceps, Spoon Forceps.
| Device ID | K935070 |
| 510k Number | K935070 |
| Device Name: | GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Paul L Sumner |
| Correspondent | Paul L Sumner KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-01-25 |