# K231783: VitroPRO

- Pathway: 510(k) (Special)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Nov 14, 2023 after 151 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875128 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222052: VitroPRO, CIVCO Medical Instruments Co., Inc. (2022) Summary page 4.

## Indications for use
This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. Transvaginal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment, and oocyte retrieval. Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

Source page: https://510kreport.com/device/K231783
Methodology: https://510kreport.com/methodology