Data / Medical devices / Instrument, Shunt System Implantation / United States
FDA-registered makers of Instrument, Shunt System Implantation in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Instrument, Shunt System Implantation (product code GYK). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Instrument, Shunt System Implantation
- Product code
- GYK
- Country
- United States
Makers of Instrument, Shunt System Implantation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Natus Medical Incorporated | San Diego, CA, United States | Complaint file establishment, Specification developer | 3 | August 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 1 | October 31, 1989 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 1 | September 30, 1988 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 1 | September 10, 1993 | 0 | 0 | 0 | api.fda.gov |
| American Benchmark Machine Works | Olympia, WA, United States | Contract manufacturer | 0 | 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 | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.