The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Endoflator 40, Endoflator 50.
| Device ID | K161554 |
| 510k Number | K161554 |
| Device Name: | ENDOFLATOR 40, ENDOFLATOR 50 |
| Classification | Insufflator, Laparoscopic |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Contact | Susie S. Chen |
| Correspondent | Nozomi Yagi KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE El Segundo, CA 90245 |
| Product Code | HIF |
| Subsequent Product Code | FCX |
| Subsequent Product Code | OSV |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2017-03-02 |
| Summary: | summary |