# K233500: Benesta Tissue Removal Device

- Pathway: 510(k) (Special)
- Applicant: Caldera Medical, Inc.
- Decided: Nov 30, 2023 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K260984: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) (2026), 0 descendants of its own

## Indications for use
The Caldera Medical BenestaTM Tissue Removal Device is intended for intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.

Source page: https://510kreport.com/device/K233500
Methodology: https://510kreport.com/methodology