# K991382: Shieldedtrocar/Cannula System, Model 101-005-101

- Pathway: 510(k) (Traditional)
- Applicant: Genicon, LC
- Decided: Jul 15, 1999 after 85 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) LifeQuest Point trocar: named in the summary without a submission number
- (no number) LifeQuest Gard trocar: named in the summary without a submission number
- (no number) LifeQuest Dexide trocar: named in the summary without a submission number

## Indications for use
The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.

Source page: https://510kreport.com/device/K991382
Methodology: https://510kreport.com/methodology