The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Insulated Biopsy Forceps, Grasping/dissecting Forecps, Flexible Forceps.
| Device ID | K944765 |
| 510k Number | K944765 |
| Device Name: | KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| 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 | KGE |
| Subsequent Product Code | FDI |
| Subsequent Product Code | GDI |
| Subsequent Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551056028 | K944765 | 000 |
| 04048551055779 | K944765 | 000 |
| 04048551055700 | K944765 | 000 |