# K121370: Vectec Disposable Pneumoperitoneum Needle

- Pathway: 510(k) (Traditional)
- Applicant: Vectec
- Decided: Aug 2, 2013 after 452 days
- Product code: FHO (Pneumoperitoneum Needle)
- 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
Longest line of descent: 1 generation back to K910855 (1991). 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)
- K970788: Pneumo-Matic Insufflation Needle, Apple Medical Corp. (1997) Summary page 2.
- K910855: Endopath Veress Needle, Symbiosis Corp. (1991) Summary page 2.

## Indications for use
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Source page: https://510kreport.com/device/K121370
Methodology: https://510kreport.com/methodology