# K981334: Laparo CO2-Pneu (and with Video Monitoring)

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Sep 10, 1998 after 150 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
Longest line of descent: 1 generation back to K934884 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934884: Model 2231  CO2 Insufflator, Richard Wolf Medical Instruments Corp. (1995) Summary page 1.
- (no number) System 4000: named in the summary without a submission number
- (no number) Medicam 900: named in the summary without a submission number
- (no number) 26012C: named in the summary without a submission number

## Indications for use
The Laparo CO2-Pneu generates and maintains pneumoperitoneum CO2 gas and can be used in diagnostic and operative laparoscopy.

Source page: https://510kreport.com/device/K981334
Methodology: https://510kreport.com/methodology