Home / 510(k) Clearances / K102683

510(k) K102683

THE ADDITION by Ob The-Addition, LLC — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2011
Date Received
September 17, 2010
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 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)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)