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510(k) K131161

EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, by CIVCO Medical Instruments Co., Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2013
Date Received
April 24, 2013
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

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  • K160806 — Verza Guidance System (August 5, 2016)
  • K131528 — NON-PYROGENIC ULTRASOUND TRANSDUCER COVER (June 11, 2013)
  • K080072 — MRI PATIENT POSITIONING DEVICES (June 4, 2008)
  • K013721 — SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (December 28, 2001)
  • K002546 — CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE (October 31, 2000)
  • K992152 — GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCA (August 17, 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)