# K033991: Modification to Laparoshield Conditioned Insufflation Set

- Pathway: 510(k) (Special)
- Applicant: Pall Medical
- Decided: Jan 22, 2004 after 30 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laparoshield Conditioned Insufflation Set: named in the summary without a submission number

## Indications for use
The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with CO02

Source page: https://510kreport.com/device/K033991
Methodology: https://510kreport.com/methodology