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HSW Resection Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173070

by Henke-Sass, Wolf GmbH

Identifiers

510(k) Number
K173070 FDA 510(k)
FDA Product Code
HIH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1690 FDA 510(k)
Regulation Number
884.1690 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HSW Resection Instruments are classified as Hysteroscope (And Accessories) under FDA nomenclature. These instruments are designed for endoscopic diagnostic and therapeutic procedures, enabling precise tissue resection, coagulation, and ablation within the uterine cavity or other internal anatomical sites. They facilitate visualization, incision, and vaporization of tissue while minimizing bleeding through controlled energy delivery.

These instruments are intended for single-use in sterile surgical settings, adhering to Class II regulatory standards. Supplied as reusable or disposable components (as indicated by the listed FEI numbers), they must be handled according to manufacturer guidelines to ensure sterility and functionality. Compliance with FDA 510(k) clearance (K173070) and regulation 884.1690 governs their use, with no MRI safety restrictions specified. Storage conditions and reprocessing protocols vary by component type and must align with validated institutional protocols.

Frequently asked questions

What is the HSW Resection Instruments device intended for?

The HSW Resection Instruments are designed for endoscopic diagnostic and therapeutic procedures, enabling precise tissue resection, coagulation, and ablation within the uterine cavity or other internal anatomical sites. They facilitate visualization, incision, and vaporization of tissue while minimizing bleeding through controlled energy delivery, as stated in the device description.

How are the HSW Resection Instruments supplied and what is their intended use regarding sterility and reuse?

The instruments are supplied as reusable or disposable components, as indicated by the listed FEI numbers, and are intended for single-use in sterile surgical settings. They must be handled according to manufacturer guidelines to ensure sterility and functionality, with reprocessing protocols varying by component type and requiring alignment with validated institutional protocols.

What regulatory pathway and classification apply to the HSW Resection Instruments?

The HSW Resection Instruments are classified as Class II devices under FDA regulation 884.1690 and received FDA 510(k) clearance (K173070) as substantially equivalent, with a traditional clearance type and product code HIH, under the Obstetrics/Gynecology specialty.

Are there any MRI safety restrictions for the HSW Resection Instruments?

No MRI safety restrictions are specified for the HSW Resection Instruments in the provided device data.

What storage conditions are required for the HSW Resection Instruments?

Storage conditions for the HSW Resection Instruments vary by component type and must align with validated institutional protocols, as no specific storage details are provided in the device data beyond this general requirement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HSW Resection Instruments (K173070) - FDA 510 (k), HSW Resection Instruments (K173070) — FDA 510(k) | Innolitics, PDF \\Storage\QS\Regulatory_Affairs\Projekte\HSW Resection Instruments\510 ..., HSW Resection Instruments 510(k) K173070 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Henke-Sass, Wolf GmbH

Sources (1)

  • FDA 510(k) K173070 24 fields · synced Oct 6, 2026