Scanlube

FDA 510(k) K031222 · Sonotech, Inc.

Substantially Equivalent

510(k) numberK031222

Submission

Device name
Scanlube
Applicant
Sonotech, Inc.
Bellingham, WA, US
Received
April 17, 2003
Decision date
July 23, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MUI – Media, Coupling, Ultrasound
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

Other 510(k)s with product code MUI

510(k)DeviceApplicantDecision
K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelMUI · Traditional Foshan Pingchuang Medical Technology Co., Ltd.06/17/2026SE
K252337EdgeFlow Gel PadMUI · Traditional Edgecare, Inc.04/24/2026SE
K242167Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional Anhui Deepblue Medical Technology Co., Ltd.09/19/2024SE
K241789Non-Sterile Ultrasound Transmission GelsMUI · Traditional Hony Medical Co., Ltd.07/24/2024SE
K232957Sterile and Non-Sterile Ultrasound GelsMUI · Traditional Jianerkang Medical Co., Ltd.12/15/2023SE
K221999Ultrasound Transmission GelsMUI · Traditional Hony Medical Co., Ltd.08/30/2022SE
K211691Ultrast GelMUI · Traditional Ultrast, Inc.12/22/2021SE
K190591Safergel Sterile Ultrasound GelMUI · Traditional Safersonic Us, Inc.10/04/2019SE
K181363EcoVue Sterile and Non-Sterile Ultrasound GelsMUI · Traditional H R Pharmaceuticals, Inc.06/13/2018SE
K163027Ultra/Phonic Free Conductivity GelMUI · Traditional Pharmaceutical Innovations, Inc.01/09/2018SE

More from Pharmaceutical Innovations, Inc.

510(k)DeviceDecision
K042619Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging CouplantMUI · Special 11/05/2004SE
K033178UltrabioMUI · Traditional 08/04/2004SE
K031894Scantec PadMUI · Special 07/18/2003SE
K013701Endo-GlideGCJ · Traditional 02/04/2002SE
K013170Scantac Membrane or Scantac StripITX · Traditional 11/13/2001SE
K984562VivosonicITX · Traditional 06/08/1999SE
K983691Scanflex Solid Couplant MembraneITX · Traditional 05/05/1999SE
K983985Hybrisonic SheathITX · Traditional 02/25/1999SE
K981028Ultra Image and Ultra ScanITX · Traditional 08/21/1998SE
K964658OasisITX · Traditional 02/14/1997SE

Questions and answers

When was Scanlube cleared by the FDA?

Scanlube (K031222) received a 510(k) decision of Substantially Equivalent on July 23, 2003, 97 days after the submission was received.

What is the product code of K031222?

The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.