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BenestaTM Tissue Removal Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192811

by Caldera Medical, Inc.

Identifiers

510(k) Number
K192811 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 Benesta Tissue Removal Device is a hysteroscope and accessory system designed for intrauterine use. It is utilized by trained gynecologists to hysteroscopically resect and remove tissue, including submucous myomas, endometrial polyps, and retained products of conception.

This device is authorized under FDA 510(k) clearance K192811. It is intended for use in clinical settings by qualified medical professionals.

Frequently asked questions

What is the Benesta Tissue Removal Device used for?

This device is designed for intrauterine use by trained gynecologists. It is specifically indicated for the hysteroscopic resection and removal of tissue, including endometrial polyps, submucous myomas, and retained products of conception.

Who is authorized to use this device?

The device is intended for use in clinical settings exclusively by qualified medical professionals, such as trained gynecologists, to ensure safe and effective operation during hysteroscopic procedures.

What is the regulatory status of the Benesta system?

The Benesta Tissue Removal Device is authorized under FDA 510(k) clearance K192811. This indicates that the device has been reviewed and cleared for market entry based on its substantial equivalence to other legally marketed devices.

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: BenestaTM Tissue Removal Device (K192811) — FDA 510(k) | Innolitics, K192811 FDA 510 (k) - BenestaTM Tissue Removal Device, BenestaTM Tissue Removal Device (K192811) — FDA 510(k) | Innolitics, BenestaTM Tissue Removal Device 510(k) K192811 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA 510(k) K192811 24 fields · synced Sep 25, 2026