Panels › Gastroenterology, Urology › Product code FJL · Class 2
Resectoscope
Regulation 876.1500
0510(k)s in 12 months (24 all time)
18recalls in 12 months (33 all time)
33recalls that name a 510(k)
Top companies in FJL
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 19 |
| KARL STORZ Endoscopy-America, Inc. | 5 | 12 |
| Corinth Medtech, Inc. | 4 | 0 |
| Richard Wolf Medical Instruments Corp. | 3 | 1 |
| Olympus Corp. | 3 | 0 |
| Gynecare Innovation Center | 2 | 0 |
| Comeg Endoscopy | 1 | 0 |
| Gyrus Medical , Ltd. | 1 | 0 |
| J-Tech, Inc. | 1 | 0 |
| Karl Storz SE & CO. KG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2024 | K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable Karl Storz SE & CO. KG, DE | FJL |
| Mar 17, 2023 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable Karl Storz Endoscopy America, Inc. | FJL |
| Feb 24, 2023 | K230205 | Veloxion System Corinth Medtech, Inc. | FJL |
| Jun 13, 2019 | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll S Corinth Medtech, Inc. | FJL |
| Mar 15, 2019 | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll S Corinth Medtech, Inc. | FJL |
| Mar 24, 2017 | K162979 | Veloxion System Corinth Medtech, Inc. | FJL |
| Dec 30, 2010 | K102663 | AED RESECTOSCOPE National Advanced Endoscopy Devices, Inc. | FJL |
| Mar 22, 2007 | K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp. | FJL |
| Mar 18, 2005 | K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES Richard Wolf Medical Instruments Corp. | FJL |
| Aug 19, 2004 | K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 Richard Wolf Medical Instruments Corp. | FJL |
| Apr 28, 2000 | K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE Gyrus Medical , Ltd., GB | FJL |
| Aug 12, 1997 | K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS Comeg Endoscopy | FJL |
| Feb 4, 1997 | K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) Gynecare Innovation Center | FJL |
| Sep 16, 1996 | K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] Gynecare Innovation Center | FJL |
| May 1, 1996 | K960757 | KARL STORZ URETER RESECTOSCOPE KARL STORZ Endoscopy-America, Inc. | FJL |
| Nov 22, 1995 | K954050 | RESECTOSCOPES KARL STORZ Endoscopy-America, Inc. | FJL |
| Jul 20, 1995 | K952574 | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS KARL STORZ Endoscopy-America, Inc. | FJL |
| Jun 21, 1994 | K934835 | FLOVAL Olympus Corp. | FJL |
| May 27, 1994 | K936038 | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) Surgical Laser Technologies, Inc. | FJL |
| Feb 9, 1994 | K934647 | KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION KARL STORZ Endoscopy-America, Inc. | FJL |
| Jul 23, 1993 | K931995 | RESECTOSCOPE SHEATH Olympus Corp. | FJL |
| Jan 13, 1992 | K904940 | OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES Olympus Corp. | FJL |
| Oct 23, 1991 | K913587 | JTECH 50 SERIES CUTTING LOOP J-Tech, Inc. | FJL |
| Dec 16, 1976 | K761242 | TEFLON COATED RESECTOSCOPE SHEATH V. Mueller O.V. Baxter Healthcare Corp. | FJL |
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