FDA product code FDA: Enteroscope And Accessories
FDA is the FDA product code for enteroscope and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 20 510(k) submissions under FDA, 5 in the last five years, from 15 different applicants. The average 510(k) review took 142 days (median 124); 170 days on average over the last three years.
Definition
To provide visualization and perform various procedures within the small intestine. 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).
Classification
| Field | Value |
|---|---|
| Device name | Enteroscope And Accessories |
| 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 FDA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 148 |
| 2020 | 1 | 260 |
| 2021 | 1 | 30 |
| 2023 | 2 | 96 |
| 2024 | 1 | 258 |
| 2025 | 1 | 161 |
| 2026 | 1 | 91 |
Compare with all 510(k) review times · Search every FDA clearance
Top FDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujifilm Corporation | 3 | 2021-10-29 |
| Aspero Medical, Inc. | 2 | 2026-05-01 |
| FUJIFILM Healthcare Americas Corporation | 2 | 2025-09-26 |
| Fujinon, Inc. | 2 | 2004-06-07 |
| Fujifilm Corporaton | 1 | 2023-01-11 |
10 more applicants have FDA clearances. See the full list in Caduvo.
Most recent FDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260314 | Aspero Medical, Inc. | Ancora-SB | 2026-05-01 | 91 |
| K251204 | FUJIFILM Healthcare Americas Corporation | FUJIFILM Stiffening Wire Device (SW-2000) | 2025-09-26 | 161 |
| K233321 | FUJIFILM Healthcare Americas Corporation | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | 2024-06-13 | 258 |
| K231323 | Aspero Medical, Inc. | Ancora-SB | 2023-08-31 | 115 |
| K223295 | Fujifilm Corporaton | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | 2023-01-11 | 77 |
Recalls for FDA devices
openFDA lists no recalls for product code FDA.
Frequently asked questions
What is FDA product code FDA?
FDA is the FDA product code for enteroscope and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDA?
Across 20 cleared submissions the average was 142 days from receipt to decision (median 124).
Which companies have the most FDA clearances?
Fujifilm Corporation (3); Aspero Medical, Inc. (2); FUJIFILM Healthcare Americas Corporation (2); Fujinon, Inc. (2); Fujifilm Corporaton (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FDA
- Run a recall and safety report across every FDA manufacturer
- Watch product code FDA 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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