Home / 510(k) Clearances / K231783

510(k) K231783

VitroPRO by CIVCO Medical Instruments Co., Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2023
Date Received
June 16, 2023
Clearance Type
Special
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 CIVCO Medical Instruments Co., Inc.

  • K222052 — VitroPRO (November 22, 2022)
  • K211270 — CIV-Clear cover (September 13, 2021)
  • K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Pro (June 9, 2017)
  • K160806 — Verza Guidance System (August 5, 2016)
  • K131161 — EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MI (September 17, 2013)
  • 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

  • K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (September 18, 2025)
  • 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)
  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)