FDA product code FED: Endoscopic Access Overtube, Gastroenterology-Urology
FED is the FDA product code for endoscopic access overtube, 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 104 510(k) submissions under FED, 26 in the last five years, from 65 different applicants. The average 510(k) review took 111 days (median 90); 104 days on average over the last three years. FDA has posted 12 recalls for FED devices, 5 initiated in the last five years.
Definition
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Access Overtube, 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) |
510(k) clearances per year for FED
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 142 |
| 2018 | 4 | 148 |
| 2019 | 5 | 140 |
| 2020 | 4 | 109 |
| 2021 | 3 | 237 |
| 2022 | 1 | 135 |
| 2023 | 3 | 149 |
| 2024 | 6 | 115 |
| 2025 | 11 | 113 |
| 2026 | 5 | 83 |
Compare with all 510(k) review times · Search every FED clearance
Top FED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neptune Medical, Inc. | 5 | 2026-09-18 |
| C.R. Bard, Inc. | 5 | 2016-03-31 |
| Boddingtons Plastics, Ltd. | 4 | 2019-05-30 |
| Coloplast A/S | 4 | 2018-09-07 |
| United States Endoscopy Group, Inc. | 4 | 2014-02-26 |
60 more applicants have FED clearances. See the full list in Caduvo.
Most recent FED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262262 | Neptune Medical, Inc. | Pathfinder Endoscope Overtube | 2026-09-18 | 78 |
| K260410 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Single Use Ureteral Access Sheath | 2026-09-11 | 214 |
| K261915 | Boston Scientific Corporation | Navigator Flex Ureteral Access Sheath Set | 2026-08-04 | 56 |
| K260965 | Calyxo, Inc. | CVAC Aspiration System | 2026-04-13 | 21 |
| K260521 | Zhuhai Pusen Medical Technology Co., Ltd. | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | 2026-04-06 | 48 |
Recalls for FED devices
12 product recalls in 7 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-02-19.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FED?
FED is the FDA product code for endoscopic access overtube, 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 FED?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FED?
Across 104 cleared submissions the average was 111 days from receipt to decision (median 90).
Which companies have the most FED clearances?
Neptune Medical, Inc. (5); C.R. Bard, Inc. (5); Boddingtons Plastics, Ltd. (4); Coloplast A/S (4); United States Endoscopy Group, Inc. (4).
Have FED devices been recalled?
Yes: 12 product recalls across 7 recall events; the most recent began 2025-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FED
- Run a recall and safety report across every FED manufacturer
- Watch product code FED 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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