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510(k) K163027

Ultra/Phonic Free Conductivity Gel by Pharmaceutical Innovations, Inc. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2018
Date Received
October 31, 2016
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 Pharmaceutical Innovations, Inc.

  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)
  • K961222 — EVRON GEL (June 26, 1996)

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)
  • 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)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)
  • K163024 — Ultra/Phonic Conductivity Gel (January 8, 2018)