Data / Medical devices / Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (OCL): 16 FDA-registered makers in 4 countries
16 establishments in 4 countries are registered with the FDA to make Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (product code OCL, Class 2, 21 CFR 878.4400). 6 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 54 510(k) clearances under this code, the latest on July 24, 2025, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCL
- Device class
- 2
- Regulation
- 878.4400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Israel | 1 |
| Italy | 1 |
| Mexico | 1 |
Makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
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, Repackager or relabeler, Specification developer | 18 | July 24, 2025 | 0 | 4 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer for export, Specification developer | 12 | December 22, 2022 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 5 | June 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. (Minneapolis, MN 55447) | Minneapolis, MN, United States | Manufacturer | 2 | April 1, 2013 | 0 | 1 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer | 1 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Apical Instruments | Redwood City, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galil Medical Ltd. | YOKNEAM Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Igea SPA | Carpi (MO) Modena, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesta | Franklin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Varian Medical Systems, Inc | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 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.