Data / Medical devices / Czechia / Olympus Medical Products Czech
Olympus Medical Products Czech: FDA-registered device maker in Prerov II Predmosti, Czechia, 15 510(k) clearances
Olympus Medical Products Czech is registered with the FDA (registration 3007960282) in Prerov II Predmosti, Czechia. It lists 7 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 23, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007960282
- Address
- Ul Telickova 457/29, Prerov II Predmosti, Czechia, 75124
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- June 16, 2008
- Registered through
- 2027
- Brand names listed
- CELON ENT SYSTEM, Cysto-urethroscopes and forceps, Electrosurgical loops, HF Resection Electrode, HF Resection Electrode Loop with Runner, HF Resection Electrodes, HF Resection electrode, cylinder, Resection Electrodes with HF cable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrosurgical | JOS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope, Ac-Powered And Accessories | GCP | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Resectoscope | FJL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2025 | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| August 3, 2021 | K210651 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 28, 2017 | K171965 | Resection Electrodes with HF cable | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 6, 2016 | K161600 | Resection Electrodes | JOS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| October 26, 2015 | K152092 | Resection Electrodes | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| June 20, 2012 | K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| July 1, 2010 | K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | FAS | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| September 26, 2003 | K032838 | CELON ENT SYSTEM | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| March 24, 2003 | K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | KNS | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| March 6, 1997 | K954488 | ROLLER ELECTRODE | HIH | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 24, 1995 | K951863 | ROLLER ELECTRODE | FAS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 29, 1994 | K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | FAS | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| June 8, 1994 | K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | HIH | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| October 1, 1990 | K903323 | RESECTOSCOPE LOOPS | KNS | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| April 2, 1979 | K790071 | ENDOSCOPE AND ACCESSORIES | GCP | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Hysteroscope (And Accessories)
- All makers of Electrode, Electrosurgical, Active, Urological
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Resectoscope
- All makers of Electrode, Electrosurgical
Updated September 23, 2025. 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.