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510(k) K153212

Sheathes Ultrasound Probe Covers by Sheathing Technologies, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
November 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Sheathing Technologies, Inc.

  • K130041 — SHEATHES STERILE ULTRASOUND GEL (February 6, 2013)
  • K112827 — SHEATHES ULTRASOND GEL (June 22, 2012)
  • 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 ITX

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  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)