FAS · Class II · 21 CFR 876.4300

FDA Product Code FAS: Electrode, Electrosurgical, Active, Urological

Leading manufacturers include C.R. Bard, Inc., Dornier Medtech America, Inc. and Olympus Winter & Ibe GmbH.

58
Total
58
Cleared
140d
Avg days
1990
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 170d recently vs 139d historically

FDA 510(k) Cleared Electrode, Electrosurgical, Active, Urological Devices (Product Code FAS)

58 devices
1–24 of 58
Cleared Dec 05, 2025
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)
Gastroenterology & Urology · 213d
Cleared Jun 27, 2025
Multi4 System
K250522
Multi4 Medical AB
Gastroenterology & Urology · 126d
Cleared Jun 12, 2024
PLASMA EDGE System
K240504
Lamidey Noury Medical
Gastroenterology & Urology · 112d
Cleared Mar 02, 2022
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
K213135
Chirurgie Innovation
Gastroenterology & Urology · 156d
Cleared Aug 03, 2021
Resection Electrodes with HF cable
K210651
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 152d
Cleared May 19, 2021
Electrosurgical accessory
K210394
Dornier Medtech America, Inc.
Gastroenterology & Urology · 98d
Cleared Dec 17, 1996
BARD COAGULATING RESECTOR MODEL (3552XX
K962538
C.R. Bard, Inc.
Gastroenterology & Urology · 172d
Cleared Oct 09, 1996
BARD V-MAX ROLLER BAR (3551XX
K961841
C.R. Bard, Inc.
Gastroenterology & Urology · 149d
Cleared Dec 21, 1994
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K944795
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d

About Product Code FAS - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code FAS since 1990, with 58 receiving FDA clearance (average review time: 140 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FAS Product Code

Recent submissions under FAS have taken an average of 170 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.

FAS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →