Data / Medical devices / Clip, Aneurysm
Clip, Aneurysm (HCH): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Clip, Aneurysm (product code HCH, Class 2, 21 CFR 882.5200). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on March 2, 2022, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HCH
- Device class
- 2
- Regulation
- 882.5200
- Medical specialty
- Neurology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| United States | 3 |
| Japan | 1 |
| Mexico | 1 |
Makers of Clip, Aneurysm
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 |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 11 | January 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| MIZUHO Corporation Gosen Factory | Gosen Niigata, Japan | Manufacturer | 3 | March 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Peter Lazic GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | April 12, 2019 | 0 | 1 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 1 | May 30, 2001 | 0 | 0 | 0 | api.fda.gov |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | August 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | March 16, 1979 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | March 16, 1979 | 0 | 0 | 0 | api.fda.gov |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | 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 | |
| Rudolf Medical GMBH + Co. KG | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 2, 2022. 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.