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Insuflow Device Model 6198

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063546

by Lexion Medical LLC

Identifiers

510(k) Number
K063546 FDA 510(k)
FDA Product Code
HIF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1730 FDA 510(k)
Regulation Number
884.1730 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Insuflow Device Model 6198 is a Laparoscopic Insufflator (HIF classification) designed to condition insufflation gases for laparoscopic procedures. It functions as an accessory to insufflators, providing heated, humidified, and filtered carbon dioxide to reduce the physiological stress of cold and dry peritoneal insufflation during surgery. The device ensures gas conditions closely mimic physiological parameters, enhancing patient comfort and procedural safety.

This device is intended for single-use in surgical settings and is classified as a Class II medical device under FDA regulations (884.1730). It is supplied sterile and requires no additional preparation beyond connection to an insufflator system. The Model 6198 adheres to MRI safety standards for non-ferromagnetic components and is authorized for use in obstetrics/gynecology procedures. Storage instructions specify protection from extreme temperatures and moisture to maintain device integrity.

Frequently asked questions

How does the Insuflow Device Model 6198 improve patient comfort during laparoscopic procedures compared to standard insufflators?

The Insuflow Device Model 6198 conditions insufflation gases by heating, humidifying, and filtering carbon dioxide before it enters the peritoneal cavity. This mimics physiological conditions, reducing the stress caused by cold and dry gas exposure during surgery, which can enhance patient comfort and procedural safety.

Is the Insuflow Device Model 6198 suitable for use in MRI environments, and why?

Yes, the Insuflow Device Model 6198 is designed with non-ferromagnetic components, making it compatible with MRI environments. This ensures it won’t interfere with MRI imaging or pose a risk of injury during or after use.

What special handling or storage precautions should be taken for the Insuflow Device Model 6198?

The device must be stored protected from extreme temperatures and moisture to maintain its integrity. Since it is sterile and intended for single-use, it should remain in its original packaging until immediately before use to preserve sterility.

What surgical specialties is the Insuflow Device Model 6198 authorized for use in, and how does this relate to its design?

The device is authorized for use in obstetrics and gynecology procedures, as indicated by its advisory committee classification. Its design—conditioning insufflation gases to physiological parameters—helps reduce peritoneal irritation, which is particularly relevant in delicate procedures like gynecological surgeries.

How is the Insuflow Device Model 6198 supplied, and what preparation is required before use?

The device is supplied sterile and ready for use. No additional preparation is required beyond connecting it to an insufflator system. It is designed for single-use, so no cleaning or reprocessing is necessary after a procedure.

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: INSUFLOW DEVICE, MODEL 6198 (K063546) — FDA 510(k) | Innolitics, Insuflow — Lexion Medical, Lexion Medical 6198M - SYSTEM, LAPAROSCOPIC, GAS CONDITN, INSUFLOW ..., Lexion 6198-SC Insuflow Unit - vimamedical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lexion Medical LLC
FDA Applicant
Lexion Medical, LLC

Sources (1)

  • FDA 510(k) K063546 24 fields · synced Sep 20, 2026