Product code FJL— Gastroenterology, Urology
Veloxion System
- Classification name
- Resectoscope
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 24
- First cleared
- Most recent
Market context for product code FJL
FDA has cleared devices under product code FJL between 1976 and 2024, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2019
- 2017
- 2010
- 2007
- 2005
- 2004
- 2000
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code FJL
Adverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FJL
- K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable
- K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable
- K230205 — Veloxion System
- 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
- K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- K162979 — Veloxion System
- K102663 — AED RESECTOSCOPE
- K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
- K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
- K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
- K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
- K971881 — COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
- K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
- K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
- K960757 — KARL STORZ URETER RESECTOSCOPE
- K954050 — RESECTOSCOPES
- K952574 — KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS
- K934835 — FLOVAL
- K936038 — SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
- K934647 — KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
- K931995 — RESECTOSCOPE SHEATH
- K904940 — OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
- K913587 — JTECH 50 SERIES CUTTING LOOP
- K761242 — TEFLON COATED RESECTOSCOPE SHEATH
Data sourced from openFDA. This site is unofficial and independent of the FDA.