Cleared Traditional

RZ Resectoscope System

K243382 · Rz Medizintechnik GmbH · Obstetrics & Gynecology
Jun 2025
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K243382 is an FDA 510(k) clearance for the RZ Resectoscope System, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Rz Medizintechnik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on June 3, 2025, 215 days after receiving the submission on October 31, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K243382 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2024
Decision Date June 03, 2025
Days to Decision 215 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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