FGBClass II
Ureteroscope And Accessories, Flexible/Rigid
21 CFR 876.1500 / Gastroenterology, Urology
FGB is the FDA product code for Ureteroscope And Accessories, Flexible/Rigid, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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...". As of , FDA records hold 117 510(k) clearances under this code, the most recent dated , and 27 recalls.
Classification record
- Product code
- FGB
- Device name
- Ureteroscope And Accessories, Flexible/Rigid
- FDA 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).
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 119
- Ingested recalls
- 28
Clearances, product code FGB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 5 |
| 2023 | 8 |
| 2024 | 16 |
| 2025 | 17 |
| 2026 | 8 |
Applicants with the most clearances
Product code FGB| Applicant | Clearances |
|---|---|
| Karl Storz Endoscopy-America, Inc. | 9 |
| Shanghai AnQing Medical Instrument Co., Ltd | 6 |
| Boston Scientific Corporation | 5 |
| C.R. Bard Inc | 5 |
| Hunan Vathin Medical Instrument Co., Ltd. | 5 |
| Richard Wolf Medical Instruments Corp. | 5 |
| Circon Video | 4 |
| Karl Storz SE & Co. KG | 4 |
| Medical Engineering Corp. | 3 |
| Olympus Medical Systems Corp. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.