# K252584: Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

- Pathway: 510(k) (Traditional)
- Applicant: Weyo Surgical Technology, Ltd.
- Decided: Jun 25, 2026 after 314 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 K001533 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222812: Insufflator, Scivita Medical Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
The Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to establish and maintain pneumoperitoneum by filling the abdominal cavity with carbon dioxide (CO2) gas and distending the cavity.

Source page: https://510kreport.com/device/K252584
Methodology: https://510kreport.com/methodology