Data / Medical devices / Endoscopic Central Control Unit
Endoscopic Central Control Unit (ODA): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Endoscopic Central Control Unit (product code ODA, Class 2, 21 CFR 876.1500). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on October 3, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ODA
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| United States | 4 |
| Japan | 2 |
| Costa Rica | 1 |
| Switzerland | 1 |
Makers of Endoscopic Central Control Unit
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 |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 6 | October 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 3 | September 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 3 | September 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | January 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 1 | March 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 1 | March 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Advantech Corporation | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Costa Rica Ltd. | La Aurora de Heredia, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MCD Medical Computers Deutschland GmbH | Huellhorst North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Endoskop Produktions GMBH | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 3, 2023. 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.