Data / Medical devices / Germany / Olympus Winter & Ibe GmbH
Olympus Winter & Ibe GmbH: FDA-registered device maker in TELTOW Brandenburg, Germany, 12 510(k) clearances
Olympus Winter & Ibe GmbH is registered with the FDA (registration 3003724334) in TELTOW Brandenburg, Germany. It lists 8 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003724334
- Address
- Berlin facility Rheinstrasse 8, TELTOW Brandenburg, Germany, 14513
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 17, 2008
- Registered through
- 2027
- Brand names listed
- CELON ELITE ESG-200, CELON ENT SYSTEM, ESG-150, ESG-300, ESG-400, Electrosurgical Generator ESG-410 and Accessories, MAJ-1869, MAJ-1870 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | HIN | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Specification developer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 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 18, 2023 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 17, 2021 | K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 28, 2021 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| November 29, 2018 | K182587 | Device Electrosurgical Generator ESG-150 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| April 26, 2018 | K180200 | ESG-300, APU-300, Pressure Reducer, MAPC Probes | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| May 4, 2016 | K160639 | Electrosurgical Generator ESG-200 | GEI | Substantially Equivalent | Olympus Winter & Ibe GmbH | accessdata.fda.gov |
| January 20, 2012 | K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 2, 2011 | K111751 | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS | HIN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 8, 2008 | K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| September 26, 2003 | K032838 | CELON ENT SYSTEM | GEI | Substantially Equivalent | Celon AG Medical Instruments | accessdata.fda.gov |
| February 22, 1996 | K955456 | OES LAPARO-THORACO VIDEOSCOPE (RIGID) | HET | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- All makers of Hysteroscope (And Accessories)
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Instrument, Ultrasonic Surgical
- All makers of Laparoscope, General & Plastic Surgery
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.