Cleared Special

Endomat Select, IBS Shaver Software, License (K201355) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201355 · Karl Storz SE & CO. KG · Obstetrics & Gynecology device
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Jul 2020
Decision
62d
Days
Class 2
Risk

K201355 is an FDA 510(k) clearance for the Endomat Select, IBS Shaver Software, License. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on July 22, 2020 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Karl Storz SE & CO. KG devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 160d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 15
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K201355.
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Endomat Select
K180735 · Karl Storz SE & CO. KG · Oct 2018
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018
GYN-Pump PH304
K173489 · W.O.M. World of Medicine GmbH · Mar 2018