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Plasma Shield

by Plasmatica, Ltd.

510(k) K221533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221533 Date12 Sep 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Plasma Shield is a device designed to provide clear, fog-free visibility during surgery by creating an ongoing super-hydrophilic activated surface on the scope lens. It prevents visibility issues by bonding liquid particles into a thin transparent film that keeps the lens wet.

Plasma Shield is supplied as a reusable system for use in laparoscopic surgery. It is authorized under FDA 510(k) clearance (K221533) with product code GCJ and was determined to be substantially equivalent. The device is manufactured by Plasmatica, Ltd. in Ra'anana, Israel.

Other devices from Plasmatica, Ltd.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Plasma Shield used for?

    Plasma Shield is designed to provide clear, fog-free visibility during surgery by creating an ongoing super-hydrophilic activated surface on the scope lens, which prevents visibility issues by bonding liquid particles into a thin transparent film that keeps the lens wet.

  • How is Plasma Shield supplied and is it reusable?

    Plasma Shield is supplied as a reusable system for use in laparoscopic surgery, meaning it can be cleaned and used multiple times according to the manufacturer's instructions for reuse.

  • What regulatory authorization does Plasma Shield have?

    Plasma Shield is authorized under FDA 510(k) clearance (K221533) with product code GCJ and was determined to be substantially equivalent to a predicate device.