Laparoshield Conditioned Insufflation Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030469 ↗

FDA Product Code

HIF

Device Class

Class II

Regulation

21 CFR Part 884.1730

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Modification to Laparoshield Conditioned Insufflation Set

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• What is the Laparoshield Conditioned Insufflation Set used for?

  The Laparoshield Conditioned Insufflation Set is an accessory to a laparoscopic insufflator that heats, humidifies, and filters the CO2 gas stream. It is intended for use in obstetrics/gynecology procedures to maintain optimal conditions during laparoscopic surgeries.

• How is the Laparoshield Conditioned Insufflation Set supplied?

  The Laparoshield Conditioned Insufflation Set is supplied as a single-use device. It consists of a silicon-coated heating wire coiled within insufflation tubing, with the patient-end wire encased in a hydrating wick for optimal gas conditioning.

• What is the filtration efficiency of the Laparoshield Conditioned Insufflation Set?

  The device functions as a high efficiency particle filter that retains >99.999% of particles at a 0.02 μm diameter, ensuring the delivery of clean, conditioned CO2 gas during laparoscopic procedures.

• What is the regulatory classification of the Laparoshield Conditioned Insufflation Set?

  The Laparoshield Conditioned Insufflation Set is regulated under FDA 510(k) clearance with product code HIF. It is classified as a Class II medical device and is authorized for use in the United States.