Data / Medical devices / Clamp, Line
Clamp, Line (FKK): 14 FDA-registered makers in 9 countries
14 establishments in 9 countries are registered with the FDA to make Clamp, Line (product code FKK, Class 1, 21 CFR 876.4730). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on December 2, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FKK
- Device class
- 1
- Regulation
- 876.4730
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Pakistan | 2 |
| Israel | 1 |
| France | 1 |
| Mexico | 1 |
| Canada | 1 |
| Germany | 1 |
| India | 1 |
| Ireland | 1 |
Makers of Clamp, Line
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 |
|---|---|---|---|---|---|---|---|---|
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Specification developer | 1 | October 31, 1980 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Castle Pines Medical, Inc. | Castle Pines, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gambro UF Solutions LLC | Plymouth, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Institut Georges Lopez | Lissieu Auvergne-Rhone-Alpes, France | 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 | |
| Lifemed of California | Chino, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro Canada Corporation | LINDSAY Ontario, Canada | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vantive Healthcare Technologies Private Limited | Bangalore Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vantive Manufacturing Limited | SWINFORD Mayo, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vantive US Healthcare LLC | Mountain Home, AR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 2, 1985. 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.