# K192822: Benesta Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Sep 9, 2020 after 344 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Benesta TM Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K192822
Methodology: https://510kreport.com/methodology