FDA product code FDI: Snare, Flexible
FDI is the FDA product code for snare, flexible. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 63 510(k) submissions under FDI, 6 in the last five years, from 40 different applicants. The average 510(k) review took 121 days (median 90); 264 days on average over the last three years. FDA has posted 18 recalls for FDI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Snare, Flexible |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| 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 FDI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2018 | 4 | 182 |
| 2019 | 3 | 152 |
| 2020 | 2 | 35 |
| 2021 | 1 | 29 |
| 2022 | 4 | 212 |
| 2023 | 1 | 263 |
| 2026 | 1 | 264 |
Top FDI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Endoscopy Group, Inc. | 10 | 2020-04-21 |
| Boston Scientific Corp | 5 | 2014-07-21 |
| Boston Scientific Corporation | 3 | 2020-10-08 |
| Horizons Intl. Corp. | 3 | 2008-12-23 |
| Micro-Tech (Nanjing) Co., Ltd. | 2 | 2026-02-21 |
35 more applicants have FDI clearances. See the full list in Caduvo.
Most recent FDI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251692 | Micro-Tech (Nanjing) Co., Ltd. | Advanced Tissue Resection Device | 2026-02-21 | 264 |
| K221713 | Hangzhou AGS MedTech Co., Ltd. | Polypectomy Snare | 2023-03-03 | 263 |
| K220846 | Incore Co., Ltd. | CORE-SNARE | 2022-11-21 | 243 |
| K220089 | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Disposable Polyp Snare | 2022-09-22 | 254 |
| K220790 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | 2022-06-27 | 102 |
Recalls for FDI devices
18 product recalls in 7 recall events; 2 initiated in the last five years and 12 still open. Most recent: 2025-10-06.
| Year | Recalls |
|---|---|
| 2020 | 7 |
| 2021 | 3 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code FDI?
FDI is the FDA product code for snare, flexible. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FDI?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDI?
Across 63 cleared submissions the average was 121 days from receipt to decision (median 90).
Which companies have the most FDI clearances?
United States Endoscopy Group, Inc. (10); Boston Scientific Corp (5); Boston Scientific Corporation (3); Horizons Intl. Corp. (3); Micro-Tech (Nanjing) Co., Ltd. (2).
Have FDI devices been recalled?
Yes: 18 product recalls across 7 recall events; the most recent began 2025-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FDI
- Run a recall and safety report across every FDI manufacturer
- Watch product code FDI 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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