# K221533: Plasma Shield

- Pathway: 510(k) (Traditional)
- Applicant: Plasmatica, Ltd.
- Decided: Sep 12, 2022 after 108 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: 4 generations back to K904871 (1991). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182080: Scope Antifogging System, Xodus Medical, Inc. (2018) Summary page 5.
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp), New Wave Surgical Corporation (2006) Summary page 5.

## Indications for use
The Plasma Shield is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens

Source page: https://510kreport.com/device/K221533
Methodology: https://510kreport.com/methodology