Data / Medical devices / Unit, Cautery, Thermal, Battery-Powered
Unit, Cautery, Thermal, Battery-Powered (HQP): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Unit, Cautery, Thermal, Battery-Powered (product code HQP, Class 2, 21 CFR 886.4115). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on July 20, 2012, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HQP
- Device class
- 2
- Regulation
- 886.4115
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Mexico | 2 |
| China | 2 |
| Italy | 1 |
Makers of Unit, Cautery, Thermal, Battery-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 4 | July 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Specification developer | 1 | July 11, 1977 | 0 | 1 | 0 | api.fda.gov |
| Fiab SPA | Vicchio Firenze, Italy | Manufacturer | 1 | September 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | July 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kirwan Surgical Products, LLC. | Marshfield, MA, United States | Manufacturer | 1 | March 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Apyx Medical Corporation | Clearwater, FL, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beaver-Visitec International, Inc. | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shun Ye Medical Company, Ltd. | Cixi Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tasco Medical Industries Co., Ltd. | Bao An District, Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 20, 2012. 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.