# K022318: Vomed Endoscopic and Urological Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Vomed Volzer Medizintechnik GmbH & Co.
- Decided: Sep 19, 2002 after 73 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insuMators to blow gas or powder into a tube, cavity, or organ. They are generally used as accessories to devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The devices are indicated for therapeutic and diagnostic laparoscopic and urological procedures. VOMED suction and irrigation tubes and handles are reusable accessories designed for the suction of fluids from wounds and body cavities andor the irrigation of surgical sites. They are general accessories of devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The suction and irrigation devices are indicated for therapeutic laparoscopic and urologic procedures.

Source page: https://510kreport.com/device/K022318
Methodology: https://510kreport.com/methodology