FDA Product Code
FDA Product Code FJL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | 2024-05-07 | Traditional | PDF ↗ |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023-03-17 | Traditional | PDF ↗ |
| K230205 | Veloxion System | Corinth Medtech, Inc. | 2023-02-24 | Special | PDF ↗ |
| 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 | Corinth Medtech, Inc. | 2019-06-13 | Special | PDF ↗ |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | Corinth Medtech, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K162979 | Veloxion System | Corinth Medtech, Inc. | 2017-03-24 | Traditional | PDF ↗ |
| K102663 | AED RESECTOSCOPE | National Advanced Endoscopy Devices, Inc. | 2010-12-30 | Traditional | PDF ↗ |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | 2007-03-22 | Traditional | PDF ↗ |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | Richard Wolf Medical Instruments Corp. | 2005-03-18 | Traditional | PDF ↗ |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | Richard Wolf Medical Instruments Corp. | 2004-08-19 | Traditional | PDF ↗ |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | Gyrus Medical , Ltd. | 2000-04-28 | Special | PDF ↗ |
| K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS | Comeg Endoscopy | 1997-08-12 | Traditional | PDF ↗ |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | Gynecare Innovation Center | 1997-02-04 | Traditional | PDF ↗ |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | Gynecare Innovation Center | 1996-09-16 | Traditional | PDF ↗ |
| K960757 | KARL STORZ URETER RESECTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1996-05-01 | Traditional | PDF ↗ |
| K954050 | RESECTOSCOPES | KARL STORZ Endoscopy-America, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K952574 | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS | KARL STORZ Endoscopy-America, Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K934835 | FLOVAL | Olympus Corp. | 1994-06-21 | Traditional | PDF ↗ |
| K936038 | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) | Surgical Laser Technologies, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K934647 | KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION | KARL STORZ Endoscopy-America, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K931995 | RESECTOSCOPE SHEATH | Olympus Corp. | 1993-07-23 | Traditional | PDF ↗ |
| K904940 | OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES | Olympus Corp. | 1992-01-13 | Traditional | PDF ↗ |
| K913587 | JTECH 50 SERIES CUTTING LOOP | J-Tech, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K761242 | TEFLON COATED RESECTOSCOPE SHEATH | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-16 | Traditional | PDF ↗ |
Product code FJL · Class II · Gastroenterology, Urology. Data: openFDA.