Cleared Special

Endomat Select, IBS Shaver Software, License

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

About This 510(k) Submission

K201355 is an FDA 510(k) clearance for the Endomat Select, IBS Shaver Software, License, 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 review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K201355 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HIG — Insufflator, Hysteroscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1700

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