# K182434: LaparoGuard

- Pathway: 510(k) (Traditional)
- Applicant: Mariner Endosurgery, Inc.
- Decided: Dec 13, 2018 after 98 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
Longest line of descent: 8 generations back to K931783 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121893: Stryker SDC3 HD Information Management System, Stryker Endoscopy (2012) Summary page 4.

## Indications for use
LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.

Source page: https://510kreport.com/device/K182434
Methodology: https://510kreport.com/methodology