FAS · Class II · 21 CFR 876.4300

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

Leading manufacturers include Olympus Winter & Ibe GmbH, Arthrocare Corp. and Northgate Technologies, Inc..

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 Sep 28, 2017
Resection Electrodes with HF cable
K171965
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Oct 26, 2015
Resection Electrodes
K152092
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Jun 20, 2012
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
K120418
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 131d
Cleared Jun 20, 2012
GYRUS AMCI PK BUTTON ELECTRODE
K120567
Gyrus Acmi, Inc.
Gastroenterology & Urology · 114d
Cleared Jan 11, 2011
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
K102781
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 106d
Cleared Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
K100275
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 150d
Cleared Feb 24, 2010
GYRUS ACMI PK BUTTON ELECTRODE
K093181
Gyrus Acmi, Inc.
Gastroenterology & Urology · 139d
Cleared Jun 19, 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029
Arthrocare Corp.
Gastroenterology & Urology · 79d
Cleared Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Jun 29, 1999
COAGULOOP
K991314
American Medical Systems, Inc.
Gastroenterology & Urology · 74d
Cleared Jul 24, 1997
AMS COAGULOOP RESECTION ELECTRODE
K971512
American Medical Systems, Inc.
Gastroenterology & Urology · 87d
Cleared May 28, 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526
Arthrocare Corp.
Gastroenterology & Urology · 106d
Cleared May 08, 1997
VAPOR-TECH SLED ELECTRODE
K970717
Northgate Technologies, Inc.
Gastroenterology & Urology · 70d
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 Oct 02, 1996
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
K953983
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 406d
Cleared May 28, 1996
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069
Arthrocare Corp.
Gastroenterology & Urology · 71d
Cleared Apr 24, 1996
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
K954710
Northgate Technologies, Inc.
Gastroenterology & Urology · 195d

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 →