Skip to content

Sterile Aquasonic Ultrasound Transmission Gel

by Parker Laboratories, Inc. 2 variants

Ref 01-01

Sterile Aquasonic Ultrasound Transmission Gel (01-01) is a device classified as Class IIa in the EU and Class II in the US made by Parker Laboratories, Inc., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-00855683006005), cleared under FDA 510(k) K802146 on 10 Oct 1980 and listed in FDA GUDID since 19 Dec 2016 (UDI-DI 00855683006005), active as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

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) K802146

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00855683006005 Basic UDI-DI 00855683006005UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00855683006005 UDI-DI Date19 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK802146 Date10 Oct 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00855683006005 registered 16 Jun 2026 Active
  • FDA 510(k) K802146 decided 10 Oct 1980 Active
  • FDA GUDID UDI-DI 00855683006005 listed 19 Dec 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1777-2018 FDA Class II initiated 13 Apr 2017

    There is a potential for the gel packets to have leaks in the packet seal.

Timeline

4 dated events

  1. Cleared FDA 510(k) K802146
  2. Listed FDA GUDID 00855683006005
  3. Recall initiated FDA recalls Z-1777-2018
  4. Registered EUDAMED B-00855683006005

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  • Withdrawn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 · GUDID

Trade name
Sterile Aquasonic 100 EUDAMED
Sterile Aquasonic GUDID
Generic name
Skin topical coupling gel
Model / Ref / Catalog
01-01, ULTRASOUND TRANSMISSION GEL
Primary DI / UDI-DI
00855683006005
Basic UDI-DI
B-00855683006005
510(k) Number
FDA product code
IYO
EMDN code
Z11049085 Various ultrasound instruments - consumables
GMDN term
Skin topical coupling gel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
01-01
GUDID
ULTRASOUND TRANSMISSION GEL
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Skin topical coupling gel

Similar devices in this category

Other devices filed under VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES.

Other devices from Parker Laboratories, Inc.

See all devices from Parker Laboratories, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)