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Laparoscope Lens Shield Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K160172

by Medeon Biodesign, Inc.

Identifiers

510(k) Number
K160172 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Laparoscope Lens Shield Device is a laparoscopic accessory designed to protect the lens of a laparoscope during minimally invasive surgery. It consists of a multi-lumen sheath with two concentric sheaths and a shielding film that slides over the laparoscope to physically shield the lens from debris, grease, blood, and bodily fluids.

This device is supplied as a sterile, single-use, disposable accessory. It has received FDA 510(k) clearance under K160172.

Frequently asked questions

What is the primary function of the Laparoscope Lens Shield Device?

This device is designed to protect the lens of a laparoscope during minimally invasive surgical procedures. It utilizes a multi-lumen sheath and a shielding film to create a physical barrier that prevents debris, grease, blood, and other bodily fluids from obscuring the lens.

Is this device intended for multiple uses?

No, the Laparoscope Lens Shield Device is supplied as a single-use, disposable accessory. It must be discarded after a single procedure to ensure patient safety and maintain the integrity of the sterile barrier.

How is the device supplied to the clinical environment?

The device is provided in a sterile state, ready for use in a clinical setting. It is manufactured by Medeon Biodesign, Inc. and has received FDA 510(k) clearance under K160172.

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: Laparoscope Lens Shield Device (K160172) — FDA 510 (k) | Innolitics, Laparoscope Lens Shield Device (LENS) (K192891) — FDA 510(k ..., K192891 FDA 510 (k) - Laparoscope Lens Shield Device (LENS), ClickClean™ UL030 The Laparoscope Lens Shield Device… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medeon Biodesign, Inc.

Sources (1)

  • FDA 510(k) K160172 24 fields · synced Sep 25, 2026