RZ Resectoscope System

FDA 510(k) K243382 · Rz Medizintechnik GmbH

Substantially Equivalent

510(k) numberK243382

Submission

Device name
RZ Resectoscope System
Applicant
Rz Medizintechnik GmbH
Tuttlingen, DE
Received
October 31, 2024
Decision date
June 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIH – Hysteroscope (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1690
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIH

510(k)DeviceApplicantDecision
K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional Zhejiang Geyi Medical Instrument Co., Ltd.09/08/2026SE
K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional Axora Medical, Inc.08/18/2026SE
K253020Strauss Surgical Resection InstrumentsHIH · Traditional American Medical Endoscopy, Inc.06/04/2026SE
K254050Manual Tissue Removal DeviceHIH · Traditional Suzhou AcuVu Medical Technology Co., Ltd.05/15/2026SE
K254251InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional Shanghai AnQing Medical Instrument Co., Ltd.02/26/2026SE
K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional Jiangsu Jiyuan Medical Technology Co., Ltd.12/18/2025SE
K252012SPY Cystoscope/HysteroscopeHIH · Special Stryker Endoscopy07/18/2025SE
K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional MacroLux Medical Technology Co., Ltd.08/16/2024SE
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special Guangzhou Red Pine Medical Instrument Co., Ltd.08/02/2024SE
K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001…HIH · Traditional Origyn Medical Technology (Hangzhou) Co., Ltd.07/26/2024SE

More from Origyn Medical Technology (Hangzhou) Co., Ltd.

510(k)DeviceDecision
K130778Discoscopes, Cervical EndoscopesHRX · Traditional 04/14/2014SE
K082902RZ Endoscopic (Minimally Invasive) Instruments and AccessoriesGEI · Traditional 12/10/2008SE

Questions and answers

When was RZ Resectoscope System cleared by the FDA?

RZ Resectoscope System (K243382) received a 510(k) decision of Substantially Equivalent on June 3, 2025, 215 days after the submission was received.

What is the product code of K243382?

The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.