FDA product code FBK: Endoscopic Injection Needle, Gastroenterology-Urology
FBK is the FDA product code for endoscopic injection needle, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 89 510(k) submissions under FBK, 18 in the last five years, from 66 different applicants. The average 510(k) review took 119 days (median 86); 161 days on average over the last three years. FDA has posted 42 recalls for FBK devices, 19 initiated in the last five years.
Definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Injection Needle, Gastroenterology-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FBK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 46 |
| 2018 | 2 | 138 |
| 2019 | 1 | 262 |
| 2020 | 2 | 323 |
| 2021 | 1 | 60 |
| 2022 | 6 | 208 |
| 2023 | 3 | 178 |
| 2024 | 4 | 184 |
| 2025 | 3 | 171 |
| 2026 | 2 | 127 |
Compare with all 510(k) review times · Search every FBK clearance
Top FBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carbon Medical Technologies, Inc. | 5 | 2026-03-31 |
| Wilson-Cook Medical, Inc. | 4 | 2011-07-19 |
| Uroplasty, Inc. | 3 | 2012-08-03 |
| Boston Scientific Corp | 3 | 2004-11-09 |
| Advanced Uroscience, Inc. | 3 | 2000-11-16 |
61 more applicants have FBK clearances. See the full list in Caduvo.
Most recent FBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260262 | Mirco-Tech (Nanjing) Co., Ltd. | Injection Needle | 2026-05-29 | 121 |
| K253598 | Carbon Medical Technologies, Inc. | InjecSURE Injection System | 2026-03-31 | 133 |
| K252021 | Changzhou New Med Micro-Medtech Co., Ltd. | Disposable Endoscopic Injection Needles | 2025-12-02 | 155 |
| K252247 | Olympus Medical Systems Corporation | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | 2025-10-16 | 90 |
| K241595 | Veol Medical Technologies Pvt , Ltd. | EzVu Visual Vasopressor injector (EV-19) | 2025-02-27 | 269 |
Recalls for FBK devices
42 product recalls in 9 recall events; 19 initiated in the last five years and 19 still open. Most recent: 2024-10-04.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 20 |
| 2022 | 8 |
| 2023 | 2 |
| 2024 | 9 |
Frequently asked questions
What is FDA product code FBK?
FBK is the FDA product code for endoscopic injection needle, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FBK?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FBK?
Across 89 cleared submissions the average was 119 days from receipt to decision (median 86).
Which companies have the most FBK clearances?
Carbon Medical Technologies, Inc. (5); Wilson-Cook Medical, Inc. (4); Uroplasty, Inc. (3); Boston Scientific Corp (3); Advanced Uroscience, Inc. (3).
Have FBK devices been recalled?
Yes: 42 product recalls across 9 recall events; the most recent began 2024-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FBK
- Run a recall and safety report across every FBK manufacturer
- Watch product code FBK 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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