FDA product code FJL: Resectoscope
FJL is the FDA product code for resectoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 24 510(k) submissions under FJL, 3 in the last five years, from 13 different applicants. The average 510(k) review took 121 days (median 84); 265 days on average over the last three years. FDA has posted 33 recalls for FJL devices, 19 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Resectoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FJL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 149 |
| 2019 | 2 | 38 |
| 2023 | 2 | 146 |
| 2024 | 1 | 265 |
Compare with all 510(k) review times · Search every FJL clearance
Top FJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corinth Medtech, Inc. | 4 | 2023-02-24 |
| KARL STORZ Endoscopy-America, Inc. | 4 | 1996-05-01 |
| Richard Wolf Medical Instruments Corp. | 3 | 2007-03-22 |
| Olympus Corp. | 3 | 1994-06-21 |
| Gynecare Innovation Center | 2 | 1997-02-04 |
8 more applicants have FJL clearances. See the full list in Caduvo.
Most recent FJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232486 | Karl Storz SE & CO. KG | KARL STORZ Monopolar Resectoscopes with HF Cable | 2024-05-07 | 265 |
| K221893 | Karl Storz Endoscopy America, Inc. | KARL STORZ Bipolar Resectoscopes with HF Cable | 2023-03-17 | 261 |
| K230205 | Corinth Medtech, Inc. | Veloxion System | 2023-02-24 | 30 |
| K191341 | Corinth Medtech, Inc. | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | 2019-06-13 | 24 |
| K190099 | Corinth Medtech, Inc. | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | 2019-03-15 | 52 |
Recalls for FJL devices
33 product recalls in 5 recall events; 19 initiated in the last five years and 19 still open. Most recent: 2025-11-11.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 18 |
Frequently asked questions
What is FDA product code FJL?
FJL is the FDA product code for resectoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FJL?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJL?
Across 24 cleared submissions the average was 121 days from receipt to decision (median 84).
Which companies have the most FJL clearances?
Corinth Medtech, Inc. (4); KARL STORZ Endoscopy-America, Inc. (4); Richard Wolf Medical Instruments Corp. (3); Olympus Corp. (3); Gynecare Innovation Center (2).
Have FJL devices been recalled?
Yes: 33 product recalls across 5 recall events; the most recent began 2025-11-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FJL
- Run a recall and safety report across every FJL manufacturer
- Watch product code FJL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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