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510(k) K112827

SHEATHES ULTRASOND GEL by Sheathing Technologies, Inc. — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
September 28, 2011
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 Sheathing Technologies, Inc.

  • K153212 — Sheathes Ultrasound Probe Covers (March 4, 2016)
  • K130041 — SHEATHES STERILE ULTRASOUND GEL (February 6, 2013)
  • K100966 — COLONOSCOPE/SIGMOIDOSCOPE SHEATHES (August 3, 2010)
  • K091828 — SHEATHESISO ULTRASOUND TRANSDUCER COVER (September 28, 2009)
  • K043425 — SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBER (February 28, 2005)
  • K990175 — SHEATHES (NON-LATEX), STERILE (April 21, 1999)

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)