The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Endomat Select.
| Device ID | K180735 |
| 510k Number | K180735 |
| Device Name: | Endomat Select |
| Classification | Insufflator, Hysteroscopic |
| Applicant | Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen, DE 78532 |
| Contact | Serkan Sezer |
| Correspondent | Nina Dusper Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen, DE 78532 |
| Product Code | HIG |
| Subsequent Product Code | BTA |
| Subsequent Product Code | GWG |
| Subsequent Product Code | HRX |
| Subsequent Product Code | LJH |
| Subsequent Product Code | OCX |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551376041 | K180735 | 000 |