# K223813: Aveta System 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Meditrina, Inc.
- Decided: Aug 21, 2023 after 244 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: 10 generations back to K950035 (1996). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213171: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral), Meditrina, Inc. (2022) Summary page 5.
- K962482: Scuba System, Gynecare, Inc. (1996) Summary page 5.

## Indications for use
AVETA SYSTEM 2.0: USING BIPOLAR RF DEVICE: -Hysteroscopy: Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 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, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and retained products of conception using a bipolar resecting device. USING MECHANICAL RESECTING DEVICES: -Hysteroscopy: The Aveta System 2.0 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. -Cystoscopy: The Aveta System 2.0 is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K223813
Methodology: https://510kreport.com/methodology