The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers, Scissors, Injection Cannulae, Cleaning Brushes.
| Device ID | K950434 |
| 510k Number | K950434 |
| Device Name: | KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| 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 | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-02 |
| Decision Date | 1995-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551075234 | K950434 | 000 |
| 04048551083079 | K950434 | 000 |
| 04048551083055 | K950434 | 000 |
| 04048551083000 | K950434 | 000 |
| 04048551081396 | K950434 | 000 |
| 04048551081372 | K950434 | 000 |
| 04048551081303 | K950434 | 000 |
| 04048551081280 | K950434 | 000 |
| 04048551080443 | K950434 | 000 |
| 04048551079386 | K950434 | 000 |
| 04048551079348 | K950434 | 000 |
| 04048551079324 | K950434 | 000 |
| 04048551079300 | K950434 | 000 |
| 04048551079249 | K950434 | 000 |
| 04048551079225 | K950434 | 000 |
| 04048551079171 | K950434 | 000 |
| 04048551079157 | K950434 | 000 |
| 04048551079133 | K950434 | 000 |
| 04048551083093 | K950434 | 000 |
| 04048551083147 | K950434 | 000 |
| 04048551075210 | K950434 | 000 |
| 04048551050576 | K950434 | 000 |
| 04048551050569 | K950434 | 000 |
| 04048551050552 | K950434 | 000 |
| 04048551050545 | K950434 | 000 |
| 04048551050538 | K950434 | 000 |
| 04048551050521 | K950434 | 000 |
| 04048551090619 | K950434 | 000 |
| 04048551090596 | K950434 | 000 |
| 04048551083437 | K950434 | 000 |
| 04048551083406 | K950434 | 000 |
| 04048551083369 | K950434 | 000 |
| 04048551083345 | K950434 | 000 |
| 04048551083338 | K950434 | 000 |
| 04048551083314 | K950434 | 000 |
| 04048551083215 | K950434 | 000 |
| 04048551083185 | K950434 | 000 |
| 04048551079119 | K950434 | 000 |