Olympus Winter & Ibe GmbH: FDA clearances and approvals
Olympus Winter & Ibe GmbH has 43 FDA 510(k) clearances (first 1997, latest 2026), across 20 product codes in 7 review panels. Median 510(k) review time: 94 days. Since 2017 its median was 93 days, against 123 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 233 |
| 2013 | 1 | 86 |
| 2014 | 4 | 183 |
| 2015 | 3 | 90 |
| 2016 | 5 | 89 |
| 2017 | 2 | 88 |
| 2018 | 3 | 92 |
| 2019 | 1 | 160 |
| 2020 | 1 | 196 |
| 2021 | 5 | 152 |
| 2022 | 0 | — |
| 2023 | 3 | 93 |
| 2024 | 0 | — |
| 2025 | 1 | 85 |
| 2026 | 1 | 83 |
Review time against the same product codes
Since 2017, Olympus Winter & Ibe GmbH's cleared 510(k)s took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 13 | 13 |
| FAS | Electrode, Electrosurgical, Active, Urological | 6 | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 | 4 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| NTN | Led Light Source | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FBP | Telescope, Rigid, Endoscopic | 1 | 1 |
| FDC | Resectoscope, Working Element | 1 | 1 |
Plus 10 more product codes.
Review panels
- General and Plastic Surgery (17)
- Gastroenterology and Urology (16)
- General Hospital (4)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (1)
- Neurology (1)
- Orthopedic (1)
Most recent Olympus Winter & Ibe GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | FAJ | 2026-05-21 | 83 |
| K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | GEI | 2025-09-23 | 85 |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | GEI | 2023-08-18 | 63 |
| K221522 | HF-cables (resusable) | GEI | 2023-01-19 | 238 |
| K223183 | Light-Guide Cables | HBI | 2023-01-13 | 93 |
| K213207 | Sheath, Stopcock Accessory | HIH | 2021-12-22 | 84 |
| K203492 | Instrument tray, for semi-rigid ureteroscope | KCT | 2021-09-15 | 300 |
| K210651 | Resection Electrodes with HF cable | FAS | 2021-08-03 | 152 |
| K203682 | Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action | GEI | 2021-05-17 | 151 |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | GEI | 2021-04-28 | 173 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olympus Winter & Ibe GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Olympus Winter & Ibe GmbH have?
Olympus Winter & Ibe GmbH has 43 FDA 510(k) clearances (first 1997, latest 2026), across 20 product codes in 7 review panels.
How long does FDA take to clear Olympus Winter & Ibe GmbH's 510(k)s?
The median time from FDA receipt to decision across Olympus Winter & Ibe GmbH's cleared 510(k)s is 94 days. Since 2017: 93 days, versus 123 days for all cleared 510(k)s in the same product codes.
What devices does Olympus Winter & Ibe GmbH make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 13); FAS (Electrode, Electrosurgical, Active, Urological, 6); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 4).
Has Olympus Winter & Ibe GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Olympus Winter & Ibe GmbH. Related entities may recall under other names.
Next steps
- See all 43 Olympus Winter & Ibe GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEI, Olympus Winter & Ibe GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.