Endomat Select, IBS Shaver Software, License
FDA 510(k) K201355 · Karl Storz SE & CO. KG
510(k) numberK201355
Submission
- Device name
- Endomat Select, IBS Shaver Software, License
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- May 21, 2020
- Decision date
- July 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261706 | Endomat Select (UP220)HIG · Traditional | Karl Storz Se & Co. KG | 07/16/2026SE |
| K251273 | Asurys Fluid Management SystemHIG · Traditional | Boston Scientific Corporation | 03/27/2026SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | Hologic, Inc. | 07/25/2024SE |
| K210628 | X-FLO Fluid Management SystemHIG · Traditional | Thermedx, LLC | 11/04/2021SE |
| K180735 | Endomat SelectHIG · Traditional | Karl Storz SE & CO. KG | 10/31/2018SE |
| K180825 | Fluent Fluid Management SystemHIG · Traditional | Hologic, Inc. | 08/03/2018SE |
| K173489 | GYN-Pump PH304HIG · Traditional | W.O.M. World of Medicine GmbH | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | W.O.M. World of Medicine GmbH | 02/05/2018SE |
| K172048 | FluidSmartHIG · Special | Thermedx, LLC | 09/05/2017SE |
| K133799 | Thermedx Fluid Managment SystemHIG · Traditional | Thermedx, LLC | 06/20/2014SE |
More from Thermedx, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | 09/01/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | 08/26/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | 08/19/2026SE |
| K261706 | Endomat Select (UP220)HIG · Traditional | 07/16/2026SE |
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | 06/03/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | 05/11/2026SE |
| K260003 | KARL STORZ Mediastinoscopes and InstrumentsEWY · Traditional | 03/02/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | 02/26/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | 02/12/2026SE |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | 12/05/2025SE |
Questions and answers
When was Endomat Select, IBS Shaver Software, License cleared by the FDA?
Endomat Select, IBS Shaver Software, License (K201355) received a 510(k) decision of Substantially Equivalent on July 22, 2020, 62 days after the submission was received.
What is the product code of K201355?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.