# K081173: Endoscopic CO2 Regulation Unit Ucr

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Dec 23, 2008 after 243 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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 K923982 (1993). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053382: Laparo-Thoraco Videoscope XLTF-Vaw, Olympus Medical Systems Corporation (2006) Summary page 2.

## Most influential descendants
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (2011), 3 descendants of its own
- K201096: CO2mbiLED (2020), 0 descendants of its own
- K190985: BAROnova Insufflation System, BAROnova Accessory Kit (2019), 0 descendants of its own
- K162332: Nexcore GI Insufflator (2016), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with Olympus XLTF-VAW Laparo-Thoraco Videoscope and other ancillary equipment for CO 2 gas and water feeding to clean the distal lens during endoscopic surgery.

Source page: https://510kreport.com/device/K081173
Methodology: https://510kreport.com/methodology