Atlas FDA

FJL

24 FDA 510(k) clearances · Product code

85 daysmedian time to decision
261 days90th percentile
24clearances measured

FDA profile

Official device name
Resectoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 54 · 2022: 74 · 2023: 74 · 2024: 34 · 2025: 68 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KARL STORZ Monopolar Resectoscopes with HF Cable (K232486)Karl Storz SE & CO. KG2024-05-07
KARL STORZ Bipolar Resectoscopes with HF Cable (K221893)Karl Storz Endoscopy America, Inc.2023-03-17
Veloxion System (K230205)Corinth Medtech, Inc.2023-02-24
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.2019-06-13
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.2019-03-15
Veloxion System (K162979)Corinth Medtech, Inc.2017-03-24
AED RESECTOSCOPE (K102663)National Advanced Endoscopy Devices, Inc.2010-12-30
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (K062720)Richard Wolf Medical Instruments Corp.2007-03-22
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES (K042523)Richard Wolf Medical Instruments Corp.2005-03-18
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (K041610)Richard Wolf Medical Instruments Corp.2004-08-19
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (K001270)Gyrus Medical , Ltd.2000-04-28
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS (K971881)Comeg Endoscopy1997-08-12
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (K964892)Gynecare Innovation Center1997-02-04
[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (K962506)Gynecare Innovation Center1996-09-16
KARL STORZ URETER RESECTOSCOPE (K960757)KARL STORZ Endoscopy-America, Inc.1996-05-01
RESECTOSCOPES (K954050)KARL STORZ Endoscopy-America, Inc.1995-11-22
KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS (K952574)KARL STORZ Endoscopy-America, Inc.1995-07-20
FLOVAL (K934835)Olympus Corp.1994-06-21
SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) (K936038)Surgical Laser Technologies, Inc.1994-05-27
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION (K934647)KARL STORZ Endoscopy-America, Inc.1994-02-09
RESECTOSCOPE SHEATH (K931995)Olympus Corp.1993-07-23
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES (K904940)Olympus Corp.1992-01-13
JTECH 50 SERIES CUTTING LOOP (K913587)J-Tech, Inc.1991-10-23
TEFLON COATED RESECTOSCOPE SHEATH (K761242)V. Mueller O.V. Baxter Healthcare Corp.1976-12-16

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Every clearance here is in the API, with alerts when new ones post.