# K142700: InsufflatOR Needle

- Pathway: 510(k) (Traditional)
- Applicant: Gynetech Pty., Ltd.
- Decided: Dec 19, 2014 after 88 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: 1 generation back to K993625 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993625: Insufflation Needle- 120MM, Model 900-200, Genicon, LC (2000) Summary page 4.

## Indications for use
The InsufflatOR Needle™ is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide, to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Source page: https://510kreport.com/device/K142700
Methodology: https://510kreport.com/methodology