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510(k) K021132

UNI-PATCH ULTRASOUND COUPLING GEL by The Ludlow Company LP — Product Code MUI

K021132 is an FDA 510(k) premarket notification submitted by The Ludlow Company LP for the device "UNI-PATCH ULTRASOUND COUPLING GEL". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. The Ludlow Company LP has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
April 9, 2002
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 The Ludlow Company LP

  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)

Other clearances for product code MUI

  • K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (June 17, 2026)
  • K252337 — EdgeFlow Gel Pad (April 24, 2026)
  • 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)

FDA data resources