Data / Medical devices / Applier, Aneurysm Clip
Applier, Aneurysm Clip (HCI): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Applier, Aneurysm Clip (product code HCI, Class 2, 21 CFR 882.4175). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 24, 2022, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HCI
- Device class
- 2
- Regulation
- 882.4175
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 2 |
| Japan | 1 |
| Poland | 1 |
Makers of Applier, Aneurysm Clip
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 | 4 | December 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| MIZUHO Corporation Gosen Factory | Gosen Niigata, Japan | Manufacturer | 3 | June 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | August 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Aesculap Chifa SP. Z O.O. | NOWY TOMYSL Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peter Lazic GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Rudolf Medical GMBH + Co. KG | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 24, 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.