The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Trocars, Cannulae And Sheaths For Endoscopic And Laparoscopic Procedures.
| Device ID | K940347 |
| 510k Number | K940347 |
| Device Name: | TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Johnathan S Kahan |
| Correspondent | Johnathan S Kahan KARL STORZ ENDOSCOPY-AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551176382 | K940347 | 000 |
| 04048551051153 | K940347 | 000 |
| 04048551051160 | K940347 | 000 |
| 04048551051191 | K940347 | 000 |
| 04048551051221 | K940347 | 000 |
| 04048551265970 | K940347 | 000 |
| 04048551265994 | K940347 | 000 |
| 04048551121030 | K940347 | 000 |
| 04048551121047 | K940347 | 000 |
| 04048551176351 | K940347 | 000 |
| 04048551176368 | K940347 | 000 |
| 04048551176375 | K940347 | 000 |
| 04048551051108 | K940347 | 000 |