FJL — Resectoscope Class II
FDA product code FJL covers "Resectoscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FJL
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232486 | karl storz se and co. kg | KARL STORZ Monopolar Resectoscopes with HF Cable | May 7, 2024 |
| K221893 | karl storz endoscopy america | KARL STORZ Bipolar Resectoscopes with HF Cable | March 17, 2023 |
| K230205 | corinth medtech | Veloxion System | February 24, 2023 |
| K191341 | corinth medtech | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo | June 13, 2019 |
| K190099 | corinth medtech | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo | March 15, 2019 |
| K162979 | corinth medtech | Veloxion System | March 24, 2017 |
| K102663 | national advanced endoscopy devices | AED RESECTOSCOPE | December 30, 2010 |
| K062720 | richard wolf medical instruments | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | March 22, 2007 |
| K042523 | richard wolf medical instruments | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR | March 18, 2005 |
| K041610 | richard wolf medical instruments | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | August 19, 2004 |
| K001270 | gyrus medical | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | April 28, 2000 |
| K971881 | comeg endoscopy | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTROD | August 12, 1997 |
| K964892 | gynecare innovation center | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | February 4, 1997 |
| K962506 | gynecare innovation center | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | September 16, 1996 |
| K960757 | karl storz endoscopy-america | KARL STORZ URETER RESECTOSCOPE | May 1, 1996 |
| K954050 | karl storz endoscopy-america | RESECTOSCOPES | November 22, 1995 |
| K952574 | karl storz endoscopy-america | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGUL | July 20, 1995 |
| K934835 | olympus | FLOVAL | June 21, 1994 |
| K936038 | surgical laser technologies | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) | May 27, 1994 |
| K934647 | karl storz endoscopy-america | KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION | February 9, 1994 |