# K243677: iovera° System

- Pathway: 510(k) (Special)
- Applicant: Pacira Biosciences, Inc.
- Decided: Dec 26, 2024 after 29 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K781302 (1978). 32 ancestors in all.
No later device cites it as a predicate yet.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220656: iovera System, Pacira Biosciences, Inc. (2022) Summary page 5.
- K211334: Iovera System, Pacira Pharmaceuticals, Inc. (2021) Summary page 5.

## Indications for use
The iovera® System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera® System is not indicated for treatment of central nervous system tissue. When stimulation compatible components are used, the iovera® System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

Source page: https://510kreport.com/device/K243677
Methodology: https://510kreport.com/methodology