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510(k) K252337

EdgeFlow Gel Pad by Edgecare, Inc. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
July 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Edgecare, Inc.

  • K252237 — EdgeFlow UW20 (April 17, 2026)
  • K231677 — EdgeFlow UH10 (March 6, 2024)

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  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • K232957 — Sterile and Non-Sterile Ultrasound Gels (December 15, 2023)
  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)