The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Suction/irrigation Tubes. Cannulae, Sheaths.
| Device ID | K945059 |
| 510k Number | K945059 |
| Device Name: | KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1994-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551365328 | K945059 | 000 |
| 04048551155608 | K945059 | 000 |
| 04048551155585 | K945059 | 000 |
| 04048551155516 | K945059 | 000 |
| 04048551155509 | K945059 | 000 |
| 04048551155462 | K945059 | 000 |
| 04048551155394 | K945059 | 000 |
| 04048551085103 | K945059 | 000 |
| 04048551290859 | K945059 | 000 |
| 04048551084748 | K945059 | 000 |
| 04048551155615 | K945059 | 000 |
| 04048551155622 | K945059 | 000 |
| 04048551310793 | K945059 | 000 |
| 04048551258651 | K945059 | 000 |
| 04048551160749 | K945059 | 000 |
| 04048551159989 | K945059 | 000 |
| 04048551155844 | K945059 | 000 |
| 04048551155837 | K945059 | 000 |
| 04048551155813 | K945059 | 000 |
| 04048551155738 | K945059 | 000 |
| 04048551155721 | K945059 | 000 |
| 04048551086841 | K945059 | 000 |