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510(k) K221999

Ultrasound Transmission Gels by Hony Medical Co., Ltd. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2022
Date Received
July 7, 2022
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 Hony Medical Co., Ltd.

  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K221278 — Transducer Probe Cover (January 11, 2023)

Other clearances for product code MUI

  • K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent (September 19, 2024)
  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • K232957 — Sterile and Non-Sterile Ultrasound Gels (December 15, 2023)
  • 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)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)