# K970788: Pneumo-Matic Insufflation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Apple Medical Corp.
- Decided: Mar 27, 1997 after 23 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
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. The FDA summary names its predicate without a number.
- (no number) Dexide, Inc. Pneumo-Needle: named in the summary without a submission number

## Most influential descendants
- K121370: Vectec Disposable Pneumoperitoneum Needle (2013), 0 descendants of its own

## Indications for use
The Pneumo-Matic Insufflation 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/K970788
Methodology: https://510kreport.com/methodology