FBKClass II
Endoscopic Injection Needle, Gastroenterology-Urology
21 CFR 876.1500 / Gastroenterology, Urology
FBK is the FDA product code for Endoscopic Injection Needle, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue". As of , FDA records hold 89 510(k) clearances under this code, the most recent dated , and 42 recalls.
Classification record
- Product code
- FBK
- Device name
- Endoscopic Injection Needle, Gastroenterology-Urology
- FDA definition
- inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
- 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
- Yes
- Ingested clearances
- 89
- Ingested recalls
- 42
Clearances, product code FBK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 5 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 4 |
| 2011 | 1 |
| 2012 | 2 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 6 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code FBK| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 6 |
| Carbon Medical Technologies, Inc. | 5 |
| Wilson-Cook Medical Inc. | 4 |
| Advanced Uroscience, Inc. | 3 |
| Cook Incorporated | 3 |
| Enteric Medical Technologies | 3 |
| Mill-Rose Laboratory | 3 |
| Olympus Medical Systems Corp. | 3 |
| Uroplasty, LLC | 3 |
| C.R. Bard Inc | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Ags MedTech (Thailand) Co., Ltd.
- Allwin Medical Devices, Inc.
- Alton Shanghai Medical Instruments Co Ltd
- Anrei Medical (HangZhou) CO., Ltd.
- Aomori Olympus Co., Ltd. Hirosaki Site
- AOMORI OLYMPUS CO., Ltd. Kuroishi Site
- Beijing Zksk Technology Co., Ltd.
- Bioteque Corp.
- Bioteque Corporation I-Lan Factory II
- Bioteque Corporation Yilan Science Park Factory
- Boston Scientific Corporation
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.