# K992182: CA Guard, LTD. PSP (Port Site Protector)

- Pathway: 510(k) (Traditional)
- Applicant: Ca Guard, Ltd.
- Decided: Jul 18, 2000 after 386 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Port-site Protector may be utilized in conjunction with cannula/trocar devices intended for general laparoscopic procedures. The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.

Source page: https://510kreport.com/device/K992182
Methodology: https://510kreport.com/methodology