FDA 510(k) Applications Submitted by CIVCO Medical Instruments Co., Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K160806 03/24/2016 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC.
K131161 04/24/2013 EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, CIVCO MEDICAL INSTRUMENTS CO., INC.
K131528 05/28/2013 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC.
K080072 01/11/2008 MRI PATIENT POSITIONING DEVICES CIVCO MEDICAL INSTRUMENTS CO., INC.
K970513 02/11/1997 GENERAL PURPOSE TRANDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC.
K970514 02/11/1997 DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO MEDICAL INSTRUMENTS CO., INC.
K970515 02/11/1997 GENERAL PURPOSE LATEX TRANSDUCER COVERS CIVCO MEDICAL INSTRUMENTS CO., INC.
K991236 04/12/1999 GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, CIVCO MEDICAL INSTRUMENTS CO., INC.
K992152 06/25/1999 GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF CIVCO MEDICAL INSTRUMENTS CO., INC.
K002546 08/17/2000 CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE CIVCO MEDICAL INSTRUMENTS CO., INC.
K211270 04/27/2021 CIV-Clear cover CIVCO Medical Instruments Co., Inc.
K222052 07/12/2022 VitroPRO CIVCO Medical Instruments Co., Inc.
K163313 11/23/2016 ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor CIVCO MEDICAL INSTRUMENTS CO., INC.
K013721 11/09/2001 SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC.


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