Data / Medical devices / Instrument, Shunt System Implantation
Instrument, Shunt System Implantation (GYK): 16 FDA-registered makers in 5 countries
16 establishments in 5 countries are registered with the FDA to make Instrument, Shunt System Implantation (product code GYK, Class 1, 21 CFR 882.4545). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 11, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GYK
- Device class
- 1
- Regulation
- 882.4545
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 4 |
| France | 2 |
| Pakistan | 1 |
| Mexico | 1 |
Makers of Instrument, Shunt System Implantation
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Sophysa | BESANCON Doubs, France | Manufacturer | 1 | September 18, 1985 | 0 | 0 | 0 | api.fda.gov |
| Sophysa | ORSAY, CEDEX Essonne, France | Manufacturer | 1 | September 18, 1985 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 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 | |
| Christoph Miethke GMBH & Co.kg | potsdam Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | 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 | |
| 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 | |
| christoph miethke gmbh & co.kg | potsdam Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 11, 1996. 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.