# K221995: Gas Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Mar 28, 2023 after 265 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: 8 generations back to K964171 (1997). 24 ancestors in all.
No later device cites it as a predicate yet.
3 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161554: Endoflator 40, Endoflator 50, KARL STORZ Endoscopy-America, Inc. (2017) Summary page 4.

## Indications for use
The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

Source page: https://510kreport.com/device/K221995
Methodology: https://510kreport.com/methodology