# K190372: Aveta System

- Pathway: 510(k) (Traditional)
- Applicant: Meditrina, Inc.
- Decided: May 16, 2019 after 90 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: 8 generations back to K950035 (1996). 41 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C, Smith & Nephew, Inc. (2015) Summary page 4.
- K123732: Hysteroscopy Pump HM6, W.O.M. World of Medicine AG (2013) Summary page 4.
- K132015: Truclear Morcellation System and Truclear Morcellators, Smith & Nephew, Inc. (2013) Summary page 4.

## Most influential descendants
- K213171: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (2022), 1 descendant of its own
- K223813: Aveta System 2.0 (2023), 0 descendants of its own
- K192100: Aveta Disposable Hysteroscope (2019), 0 descendants of its own
- K191958: Aveta System (2019), 0 descendants of its own

## 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/K190372
Methodology: https://510kreport.com/methodology