# K221897: Hydrozid Precise

- Pathway: 510(k) (Traditional)
- Applicant: Bibawo Medical A/S
- Decided: May 30, 2023 after 334 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881349 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201740: Hydrozid, Medilink A/S (2021) Summary page 4.

## Indications for use
Hydrozid Precise contains 1,1,1,2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of verruca (warts), including plantar warts, seborrheic keratosis, actinic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Source page: https://510kreport.com/device/K221897
Methodology: https://510kreport.com/methodology