Cleared Traditional

Resection Electrodes with HF cable

K210651 · Olympus Winter & Ibe GmbH · Obstetrics & Gynecology
Aug 2021
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K210651 is an FDA 510(k) clearance for the Resection Electrodes with HF cable, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on August 3, 2021, 152 days after receiving the submission on March 4, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K210651 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2021
Decision Date August 03, 2021
Days to Decision 152 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code FAS — Electrode, Electrosurgical, Active, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

Similar Devices — FAS Electrode, Electrosurgical, Active, Urological

All 57
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 )
K251403 · Dornier Medtech America Inc (Dmta) · Dec 2025
Multi4 System
K250522 · Multi4 Medical AB · Jun 2025
PLASMA EDGE System
K240504 · Lamidey Noury Medical · Jun 2024
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
K213135 · Chirurgie Innovation · Mar 2022
Electrosurgical accessory
K210394 · Dornier Medtech America, Inc. · May 2021
Resection Electrodes with HF cable
K171965 · Olympus Winter & Ibe GmbH · Sep 2017

More from Olympus Winter & Ibe GmbH

View all
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
K252043 · GEI · Sep 2025
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)
K231777 · GEI · Aug 2023
HF-cables (resusable)
K221522 · GEI · Jan 2023
Light-Guide Cables
K223183 · HBI · Jan 2023
Sheath, Stopcock Accessory
K213207 · HIH · Dec 2021