The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Autocon Iii 400.
| Device ID | K171717 |
| 510k Number | K171717 |
| Device Name: | AUTOCON III 400 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Annalisa Smullin |
| Correspondent | Dawn M Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-09 |
| Decision Date | 2017-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551378809 | K171717 | 000 |