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510(k) K043425

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) by Sheathing Technologies, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2005
Date Received
December 13, 2004
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.

  • K153212 — Sheathes Ultrasound Probe Covers (March 4, 2016)
  • 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)
  • K990175 — SHEATHES (NON-LATEX), STERILE (April 21, 1999)

Other clearances for product code ITX

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  • 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)