Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJL — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
261 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | 2024-05-07 | 265 | 0 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023-03-17 | 261 | 0 |
| K230205 | Veloxion System | Corinth Medtech, Inc. | 2023-02-24 | 30 | 0 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxio | Corinth Medtech, Inc. | 2019-06-13 | 24 | 0 |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxio | Corinth Medtech, Inc. | 2019-03-15 | 52 | 0 |
| K162979 | Veloxion System | Corinth Medtech, Inc. | 2017-03-24 | 149 | 0 |
| K102663 | AED RESECTOSCOPE | National Advanced Endoscopy Devices, Inc. | 2010-12-30 | 106 | 0 |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | 2007-03-22 | 191 | 1 |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE | Richard Wolf Medical Instruments Corp. | 2005-03-18 | 182 | 0 |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUM | Richard Wolf Medical Instruments Corp. | 2004-08-19 | 65 | 0 |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRO | Gyrus Medical , Ltd. | 2000-04-28 | 8 | 0 |
| K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/U | Comeg Endoscopy | 1997-08-12 | 84 | 0 |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | Gynecare Innovation Center | 1997-02-04 | 60 | 0 |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | Gynecare Innovation Center | 1996-09-16 | 81 | 0 |
| K960757 | KARL STORZ URETER RESECTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1996-05-01 | 68 | 0 |
| K954050 | RESECTOSCOPES | KARL STORZ Endoscopy-America, Inc. | 1995-11-22 | 85 | 0 |
| K952574 | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL | KARL STORZ Endoscopy-America, Inc. | 1995-07-20 | 45 | 0 |
| K934835 | FLOVAL | Olympus Corp. | 1994-06-21 | 256 | 0 |
| K936038 | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) | Surgical Laser Technologies, Inc. | 1994-05-27 | 158 | 0 |
| K934647 | KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION | KARL STORZ Endoscopy-America, Inc. | 1994-02-09 | 133 | 12 |
| K931995 | RESECTOSCOPE SHEATH | Olympus Corp. | 1993-07-23 | 91 | 18 |
| K904940 | OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES | Olympus Corp. | 1992-01-13 | 438 | 0 |
| K913587 | JTECH 50 SERIES CUTTING LOOP | J-Tech, Inc. | 1991-10-23 | 72 | 0 |
| K761242 | TEFLON COATED RESECTOSCOPE SHEATH | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-16 | 3 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda