# K191958: Aveta System

- Pathway: 510(k) (Special)
- Applicant: Meditrina, Inc.
- Decided: Oct 1, 2019 after 70 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K950035 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190372: Aveta System, Meditrina, Inc. (2019) Summary page 4.

## Indications for use
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.

Source page: https://510kreport.com/device/K191958
Methodology: https://510kreport.com/methodology