# K161421: Single Use Surgical Suction Irrigator

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Haize Medical Scientific Development Co., Ltd.
- Decided: Jun 24, 2016 after 32 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250130: Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) (2025), 0 descendants of its own

## Indications for use
The Single Use Surgical Suction Irrigator is indicated to provide suction and irrigation functions in general surgery and laparoscopic surgery to help remove dropsy, hematocele and tissue debris by vacuum aspiration and deliver irrigation fluids to surgical site.

Source page: https://510kreport.com/device/K161421
Methodology: https://510kreport.com/methodology