The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Trocard, Flexible Trocar Sleeves.
| Device ID | K945751 |
| 510k Number | K945751 |
| Device Name: | KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Judith K Murphy |
| Correspondent | Judith K Murphy 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 | 1994-11-23 |
| Decision Date | 1994-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551159170 | K945751 | 000 |
| 04048551159149 | K945751 | 000 |