The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz New Generation Trocars.
| Device ID | K180977 |
| 510k Number | K180977 |
| Device Name: | KARL STORZ New Generation Trocars |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Annalisa Smullin |
| Correspondent | Annalisa Smullin KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551400265 | K180977 | 000 |
| 04048551400241 | K180977 | 000 |
| 04048551400227 | K180977 | 000 |
| 04048551400203 | K180977 | 000 |
| 04048551400142 | K180977 | 000 |
| 04048551360149 | K180977 | 000 |