Data / Medical devices / Device, Surgical, Cryogenic
Device, Surgical, Cryogenic (GXH): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Device, Surgical, Cryogenic (product code GXH, Class 2, 21 CFR 882.4250). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on April 10, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GXH
- Device class
- 2
- Regulation
- 882.4250
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
Makers of Device, Surgical, Cryogenic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer | 7 | April 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pacira Pharmaceuticals, INC | San Diego, CA, United States | Complaint file establishment, Manufacturer | 3 | December 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Epimed International, Inc. | Johnstown, NY, United States | Manufacturer | 1 | April 30, 1986 | 0 | 0 | 0 | api.fda.gov |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.