The following data is part of a premarket notification filed by Karl Storz Se & Co. Kg with the FDA for Endomat Select, Ibs Shaver Software, License.
| Device ID | K201355 |
| 510k Number | K201355 |
| Device Name: | Endomat Select, IBS Shaver Software, License |
| Classification | Insufflator, Hysteroscopic |
| Applicant | Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 34 Tuttlingen, DE 78532 |
| Contact | Alexey Davidov |
| Correspondent | Alexey Davidov Karl Storz SE & Co. KG Dr.-Karl-Storz-Strasse 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2020-07-22 |