FDA product code FGB: Ureteroscope And Accessories, Flexible/Rigid
FGB is the FDA product code for ureteroscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 119 510(k) submissions under FGB, 54 in the last five years, from 64 different applicants. The average 510(k) review took 131 days (median 115); 148 days on average over the last three years. FDA has posted 28 recalls for FGB devices, 23 initiated in the last five years.
Definition
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Ureteroscope And Accessories, Flexible/Rigid |
| 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 FGB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 38 |
| 2018 | 4 | 162 |
| 2019 | 2 | 197 |
| 2020 | 2 | 134 |
| 2021 | 3 | 180 |
| 2022 | 5 | 177 |
| 2023 | 8 | 174 |
| 2024 | 16 | 174 |
| 2025 | 17 | 139 |
| 2026 | 8 | 131 |
Compare with all 510(k) review times · Search every FGB clearance
Top FGB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shanghai AnQing Medical Instrument Co., Ltd. | 6 | 2025-10-03 |
| KARL STORZ Endoscopy-America, Inc. | 6 | 2014-10-23 |
| Boston Scientific Corporation | 5 | 2026-08-26 |
| Hunan Vathin Medical Instrument Co., Ltd. | 5 | 2025-05-06 |
| C.R. Bard, Inc. | 5 | 1992-10-08 |
59 more applicants have FGB clearances. See the full list in Caduvo.
Most recent FGB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261447 | Calyxo, Inc. | CVAC® Aspiration System | 2026-09-15 | 137 |
| K262488 | Guangzhou Red Pine Medical Instrument Co., Ltd. | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | 2026-09-09 | 51 |
| K261153 | Boston Scientific Corporation | LithoVue Elite Digital Flexible Ureteroscope System | 2026-08-26 | 140 |
| K262552 | Scivita Medical Technology Co., Ltd. | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | 2026-08-14 | 21 |
| K253505 | Roen Surgical, Inc. | Zamenix P | 2026-08-07 | 280 |
Recalls for FGB devices
28 product recalls in 8 recall events; 23 initiated in the last five years and 23 still open. Most recent: 2026-07-22.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 6 |
| 2023 | 1 |
| 2024 | 15 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FGB?
FGB is the FDA product code for ureteroscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FGB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGB?
Across 119 cleared submissions the average was 131 days from receipt to decision (median 115).
Which companies have the most FGB clearances?
Shanghai AnQing Medical Instrument Co., Ltd. (6); KARL STORZ Endoscopy-America, Inc. (6); Boston Scientific Corporation (5); Hunan Vathin Medical Instrument Co., Ltd. (5); C.R. Bard, Inc. (5).
Have FGB devices been recalled?
Yes: 28 product recalls across 8 recall events; the most recent began 2026-07-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FGB
- Run a recall and safety report across every FGB manufacturer
- Watch product code FGB 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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