OES ELITE Cystoscope and Accessories +11 more— 510(k) K260649

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

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2026-02-27

Decision date

2026-05-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hamburg, DE

• K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more2026-05-11
• K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more2026-04-16
• K253905 — PrimeSight UltraView System2026-04-07
• K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments2026-03-27
• K253226 — UV5000W Handle2025-10-23

• K252043 — Bipolar applicator CelonProBreath (WB990310) +3 more2025-09-23
• K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)2023-08-18
• K221522 — HF-cables (resusable)2023-01-19
• K223183 — Light-Guide Cables2023-01-13
• K213207 — Sheath, Stopcock Accessory2021-12-22

Injury

533

Malfunction

6,705

Total

7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →