Data / Medical devices / Light, Surgical, Endoscopic
Light, Surgical, Endoscopic (FSW): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Light, Surgical, Endoscopic (product code FSW, Class 2, 21 CFR 878.4580). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on November 25, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FSW
- Device class
- 2
- Regulation
- 878.4580
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| India | 1 |
| China | 1 |
Makers of Light, Surgical, Endoscopic
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 |
|---|---|---|---|---|---|---|---|---|
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Manufacturer | 1 | November 18, 1993 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | November 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | November 25, 2002 | 0 | 0 | 0 | api.fda.gov |
| Eclipse Prism Medical Devices Pvt. Ltd | RABALE, NAVI MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Long Island Technology Group LLC | Woodbury, NY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rusun Medical Co., Ltd | Yichun City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 25, 2002. 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.