FJL · Class II · 21 CFR 876.1500

FDA Product Code FJL: Resectoscope

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Corinth Medtech, Inc. and Richard Wolf Medical Instruments Corp..

25
Total
25
Cleared
127d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 265d recently vs 121d historically

FDA 510(k) Cleared Resectoscope Devices (Product Code FJL)

25 devices
1–24 of 25
Cleared Oct 26, 2026
Cysto-Urethroscopes and accessories
K260350
Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
Gastroenterology & Urology · 265d
Cleared May 07, 2024
KARL STORZ Monopolar Resectoscopes with HF Cable
K232486
Karl Storz SE & CO. KG
Gastroenterology & Urology · 265d
Cleared Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
K221893
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 261d
Cleared Feb 24, 2023
Veloxion System
K230205
Corinth Medtech, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 13, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
K191341
Corinth Medtech, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 15, 2019
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
K190099
Corinth Medtech, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 24, 2017
Veloxion System
K162979
Corinth Medtech, Inc.
Gastroenterology & Urology · 149d
Cleared Dec 30, 2010
AED RESECTOSCOPE
K102663
National Advanced Endoscopy Devices, Inc.
Gastroenterology & Urology · 106d
Cleared Mar 22, 2007
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 191d
Cleared Mar 18, 2005
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
K042523
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 182d
Cleared Aug 19, 2004
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
K041610
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 65d
Cleared Apr 28, 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
K001270
Gyrus Medical , Ltd.
Gastroenterology & Urology · 8d
Cleared Aug 12, 1997
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
K971881
Comeg Endoscopy
Gastroenterology & Urology · 84d
Cleared Feb 04, 1997
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
K964892
Gynecare Innovation Center
Gastroenterology & Urology · 60d
Cleared Sep 16, 1996
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
K962506
Gynecare Innovation Center
Gastroenterology & Urology · 81d
Cleared May 01, 1996
KARL STORZ URETER RESECTOSCOPE
K960757
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 68d
Cleared Nov 22, 1995
RESECTOSCOPES
K954050
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 20, 1995
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS
K952574
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 45d
Cleared Jun 21, 1994
FLOVAL
K934835
Olympus Corp.
Gastroenterology & Urology · 256d
Cleared May 27, 1994
SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
K936038
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 158d
Cleared Feb 09, 1994
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
K934647
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 133d
Cleared Jul 23, 1993
RESECTOSCOPE SHEATH
K931995
Olympus Corp.
Gastroenterology & Urology · 91d
Cleared Jan 13, 1992
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
K904940
Olympus Corp.
Gastroenterology & Urology · 438d
Cleared Oct 23, 1991
JTECH 50 SERIES CUTTING LOOP
K913587
J-Tech, Inc.
Gastroenterology & Urology · 72d

About Product Code FJL - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code FJL since 1976, with 25 receiving FDA clearance (average review time: 127 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - FJL Product Code

Recent submissions under FJL have taken an average of 265 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.

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