# K182080: Scope Antifogging System

- Pathway: 510(k) (Traditional)
- Applicant: Xodus Medical, Inc.
- Decided: Sep 19, 2018 after 48 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: 3 generations back to K904871 (1991). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp), New Wave Surgical Corporation (2006) Summary page 4.

## Most influential descendants
- K221533: Plasma Shield (2022), 0 descendants of its own

## Indications for use
The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens.

Source page: https://510kreport.com/device/K182080
Methodology: https://510kreport.com/methodology