OES ELITE Cystoscope and Accessories +11 more— 510(k) K260649
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K260649 for OES ELITE Cystoscope and Accessories +11 more, Substantially Equivalent on 2026-05-21. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Summary
Olympus Winter & Ibe's record starts with the OES ELITE Cystoscope and Accessories, then lists obturators by size and model number, starting with Obturator, 17 Fr. (WA2C17BO). The device name is cut off partway through that list. The product code is FAJ, flexible or rigid cystoscopes and accessories.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Olympus filed from Hamburg, Germany. Review took 83 calendar days (February 27 to May 21, 2026).
Clearance details
- Device name as filed
- 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,
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Product code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
Recent devices under product code FAJ
view all- K263075 — Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more
- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more
- K253905 — PrimeSight UltraView System
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
More clearances from Olympus Winter & Ibe GmbH
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.