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Snap Kovers

by Advance Medical Designs, Inc.

510(k) K850959

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K850959↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK850959 Date9 Apr 1985ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-1036-04 FDA Unclassified (pre-2012) initiated 18 Jun 2004

    The product may come apart when excessive force is applied to the coupler.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Equipment Snap Kovers
510(k) Number
FDA product code
JAA
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Snap Kovers are protective covers designed for shielding medical imaging equipment. These covers serve as physical barriers to prevent contamination and maintain cleanliness, ensuring equipment remains free from dust, moisture, and other environmental hazards during storage or transport. They are specifically engineered for use with X-ray, fluoroscopic, and image-intensified systems, helping preserve their functionality and longevity.

Snap Kovers are supplied in reusable, non-sterile form and are available in multiple sizes, including 40" x 60", 40" x 36", and 40" x 30". They are intended for use in radiology settings and are compatible with MRI-safe environments. The device holds FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for medical equipment protection. Proper storage involves keeping covers clean and dry, away from direct sunlight or extreme temperatures.

From the manufacturer

SNAP KOVERS, 40"x 36" • Advance Medical Designs, Inc..

Source: advancemedicaldesigns.com

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Questions

AI-generated answers, 20 Sep 2026

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

  • Are the Snap Kovers designed for single-use or can they be reused? Why?

    The Snap Kovers are explicitly supplied as reusable covers. Since they are non-sterile and engineered to protect medical imaging equipment from contamination during storage or transport, their durable design supports repeated use. This makes them cost-effective for radiology settings where equipment must remain clean and protected over time.

  • What sizes are available for the Snap Kovers, and which imaging systems are they compatible with?

    The Snap Kovers come in three standard sizes: 40" x 60", 40" x 36", and 40" x 30". They are specifically designed for shielding X-ray, fluoroscopic, and image-intensified systems, ensuring a secure barrier against dust, moisture, and environmental hazards. Their compatibility extends to MRI-safe environments, making them versatile for various radiology applications.

  • How should I store the Snap Kovers to maintain their effectiveness?

    To preserve the Snap Kovers, store them in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are reusable, keeping them free of debris and moisture ensures they continue to provide a reliable barrier for protecting imaging equipment during storage or transport.

  • Are the Snap Kovers sterile, and if not, what does that mean for their use in a clinical setting?

    The Snap Kovers are non-sterile, meaning they are not intended for direct patient contact or sterile procedures. Their purpose is to protect imaging equipment from contamination during handling, storage, or transport, not to maintain a sterile field. This makes them suitable for shielding equipment in radiology settings where sterility is not required for the covers themselves.

  • What regulatory pathways have the Snap Kovers undergone, and what does that mean for their use?

    The Snap Kovers hold FDA 510(k) clearance and MDD authorization, indicating they meet regulatory standards for medical equipment protection. The FDA’s 510(k) process confirms they are substantially equivalent to a legally marketed device, while MDD authorization aligns with European medical device regulations. This ensures compliance with safety and performance requirements for use in radiology environments.