Resectoscope
FDA product code FJL · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
24510(k) clearances
0PMA approvals
33recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 5
- Corinth Medtech, Inc. 4
- Olympus Corp. 3
- Richard Wolf Medical Instruments Corp. 3
- Gynecare Innovation Center 2
- V. Mueller O.V. Baxter Healthcare Corp. 1
- J-Tech, Inc. 1
- Surgical Laser Technologies, Inc. 1
- Comeg Endoscopy 1
- Gyrus Medical, Inc. 1
- National Advanced Endoscopy Devices, Inc. 1
- Karl Storz SE & CO. KG 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF CableFJL · Traditional | Karl Storz SE & CO. KG | 05/07/2024SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | Karl Storz Endoscopy America, Inc. | 03/17/2023SE |
| K230205 | Veloxion SystemFJL · Special | Corinth Medtech, Inc. | 02/24/2023SE |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…FJL · Special | Corinth Medtech, Inc. | 06/13/2019SE |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…FJL · Traditional | Corinth Medtech, Inc. | 03/15/2019SE |
| K162979 | Veloxion SystemFJL · Traditional | Corinth Medtech, Inc. | 03/24/2017SE |
| K102663 | AED ResectoscopeFJL · Traditional | National Advanced Endoscopy Devices, Inc. | 12/30/2010SE |
| K062720 | S-Line Bipolar Resectoscopes and Bipolar ElectrodesFJL · Traditional | Richard Wolf Medical Instruments Corp. | 03/22/2007SE |
| K042523 | Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, AccessoriesFJL · Traditional | Richard Wolf Medical Instruments Corp. | 03/18/2005SE |
| K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207FJL · Traditional | Richard Wolf Medical Instruments Corp. | 08/19/2004SE |
| K001270 | Gyrus Endourology System: Axipolar Resectoscope Loop ElectrodeFJL · Special | Gyrus Medical , Ltd. | 04/28/2000SE |
| K971881 | Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarr…FJL · Traditional | Comeg Endoscopy | 08/12/1997SE |
| K964892 | Femrx Turp SR System (TS27XX-YY/TS24XX-YY)FJL · Traditional | Gynecare Innovation Center | 02/04/1997SE |
| K962506 | [Specialized Tissue Aspirating Resectoscope (Star)]FJL · Traditional | Gynecare Innovation Center | 09/16/1996SE |
| K960757 | Karl Storz Ureter ResectoscopeFJL · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/01/1996SE |
| K954050 | ResectoscopesFJL · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/22/1995SE |
| K952574 | Karl Storz Insulated Grooved, Skiked, Ablator, Fixed Barrel with Grooves, Coagulating…FJL · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/20/1995SE |
| K934835 | FlovalFJL · Traditional | Olympus Corp. | 06/21/1994SE |
| K936038 | SLT Laser Continuous Flow Tesectoscope (CFR)FJL · Traditional | Surgical Laser Technologies, Inc. | 05/27/1994SE |
| K934647 | Karl Storz Cutting Loop Electrodes ModificationFJL · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/09/1994SE |
| K931995 | Resectoscope SheathFJL · Traditional | Olympus Corp. | 07/23/1993SE |
| K904940 | Olympus Infant Resectoscope and AccessoriesFJL · Traditional | Olympus Corp. | 01/13/1992SE |
| K913587 | Jtech 50 Series Cutting LoopFJL · Traditional | J-Tech, Inc. | 10/23/1991SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1457-2026 Class II | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1456-2026 Class II | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1455-2026 Class II | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1453-2026 Class II | Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1452-2026 Class II | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1451-2026 Class II | Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1450-2026 Class II | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1448-2026 Class II | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1447-2026 Class II | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1446-2026 Class II | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1445-2026 Class II | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1444-2026 Class II | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1443-2026 Class II | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1442-2026 Class II | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T.…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1441-2026 Class II | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1440-2026 Class II | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1439-2026 Class II | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1438-2026 Class II | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-0424-2023 Class II | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657SAn incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to… | Olympus Corporation of the Americas | 11/04/2022Open, Classified |
| Z-2246-2021 Class II | CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323Product labeled as Cutting Electrode may contain BIVAP electrode. | Richard Wolf GmbH | 06/25/2021Terminated |
| Z-0145-2014 Class II | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization…Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization… | Richard Wolf Medical Instruments Corp. | 09/18/2013Terminated |
| Z-1316-2013 Class II | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1315-2013 Class II | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie.…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1314-2013 Class II | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1313-2013 Class II | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1312-2013 Class II | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1311-2013 Class II | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie.…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1310-2013 Class II | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1309-2013 Class II | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1308-2013 Class II | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1307-2013 Class II | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1306-2013 Class II | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |
| Z-1305-2013 Class II | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting…Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may… | Karl Storz Endoscopy America Inc | 06/01/2009Terminated |