# K060723: 40 L High Flow Insufflator F113

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: May 25, 2006 after 69 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: 3 generations back to K964171 (1997). 10 ancestors in all.
45 later devices descend from it; 1 cites it directly.
2 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030837: 40 L High Flow Insufflator F108, W.O.M. World of Medicine AG (2004) Summary page 1.
- K030512: Guidant Vasoview Endoscopic Vessel Harvesting System, Guidant Corp. (2003) Summary page 3.
- K981700: Vasoview Dissection/Vessel Harvesting System, Origin Medsystems, Inc. (1998) Summary page 1.
- K031846: Cardiovations Optical Bipolar Device, ETHICON, Inc. (2003) Summary page 1.

## Most influential descendants
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own
- K143404: SurgiQuest AirSeal iFS System (2015), 27 descendants of its own

## Indications for use
The 40 L High Flow Insufflator Fl 13 is a C02 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F 113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

Source page: https://510kreport.com/device/K060723
Methodology: https://510kreport.com/methodology