ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES— 510(k) K120418

Clearance details

Applicant

Olympus Winter & Ibe GmbH

Product code

Code FAS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2012-02-10

Decision date

2012-06-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Center Valley, PA, US

• K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )2025-12-05
• K250522 — Multi4 System2025-06-27
• K240504 — PLASMA EDGE System2024-06-12
• K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge2022-03-02
• K210651 — Resection Electrodes with HF cable2021-08-03

• K260649 — OES ELITE Cystoscope and Accessories +11 more2026-05-21
• 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

Death

3

Injury

344

Malfunction

1,130

Total

1,477

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 →

• Z-2413-2023 — HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566SClass II·Ongoing·Olympus Corporation of the Americas·20230608
• Z-0754-2017 — HF Cable WA00014A, Endoscopic electrosurgical unit and accessoriesClass II·Terminated·Olympus Corporation of the Americas·20161103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120418.