# K963359: Insufflation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Sep 24, 1996 after 29 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 no predicate by number.

## Most influential descendants
- K041795: Modification to Optical Separator System (2004), 2 descendants of its own
- K111002: Reprocessed Endoscopic Trocars (2011), 0 descendants of its own
- K063788: Reprocessed Endoscopic Trocars and Cannulas (2007), 0 descendants of its own

## Indications for use
The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery.

Source page: https://510kreport.com/device/K963359
Methodology: https://510kreport.com/methodology