K201355 is an FDA 510(k) clearance for the Endomat Select, IBS Shaver Software, License. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on July 22, 2020, 62 days after receiving the submission on May 21, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K201355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2020 |
| Decision Date | July 22, 2020 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIG — Insufflator, Hysteroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1700 |