# K162648: U-Blade Veress Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.
- Decided: Dec 12, 2016 after 81 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: 2 generations back to K993625 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111441: Unimax Veress Needle, Unimax Medical Systems, Inc. (2011) Summary page 4.

## Indications for use
The U-Blade Veress 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/K162648
Methodology: https://510kreport.com/methodology