Product Code: FJL FDA class 2 21 CFR 876.1500

Resectoscope

Gastroenterology, Urology

The Resectoscope is an endoscopic instrument used via the urethra to perform transurethral resection of prostatic tissue, bladder tumors, or other urological lesions using electrical cutting loops under direct vision. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FJL, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FJL
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232486	KARL STORZ Monopolar Resectoscopes with HF Cable	May 07, 2024	Substantially Equivalent	Karl Storz SE & CO. KG
K221893	KARL STORZ Bipolar Resectoscopes with HF Cable	Mar 17, 2023	Substantially Equivalent	Karl Storz Endoscopy America, Inc.
K230205	Veloxion System	Feb 24, 2023	Substantially Equivalent	Corinth Medtech, Inc.
K191341	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags	Jun 13, 2019	Substantially Equivalent	Corinth Medtech, Inc.
K190099	Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch	Mar 15, 2019	Substantially Equivalent	Corinth Medtech, Inc.
K162979	Veloxion System	Mar 24, 2017	Substantially Equivalent	Corinth Medtech, Inc.
K102663	AED RESECTOSCOPE	Dec 30, 2010	Substantially Equivalent	National Advanced Endoscopy Devices, Inc.
K062720	S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES	Mar 22, 2007	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K042523	RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES	Mar 18, 2005	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K041610	MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207	Aug 19, 2004	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K001270	GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE	Apr 28, 2000	Substantially Equivalent	Gyrus Medical , Ltd.
K971881	COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS	Aug 12, 1997	Substantially Equivalent	Comeg Endoscopy
K964892	FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)	Feb 04, 1997	Substantially Equivalent	Gynecare Innovation Center
K962506	[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]	Sep 16, 1996	Substantially Equivalent	Gynecare Innovation Center
K960757	KARL STORZ URETER RESECTOSCOPE	May 01, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K954050	RESECTOSCOPES	Nov 22, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K952574	KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS	Jul 20, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K934835	FLOVAL	Jun 21, 1994	Substantially Equivalent	Olympus Corp.
K936038	SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)	May 27, 1994	Substantially Equivalent	Surgical Laser Technologies, Inc.
K934647	KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION	Feb 09, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K931995	RESECTOSCOPE SHEATH	Jul 23, 1993	Substantially Equivalent	Olympus Corp.
K904940	OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES	Jan 13, 1992	Substantially Equivalent	Olympus Corp.
K913587	JTECH 50 SERIES CUTTING LOOP	Oct 23, 1991	Substantially Equivalent	J-Tech, Inc.
K761242	TEFLON COATED RESECTOSCOPE SHEATH	Dec 16, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.