FDA product code FDS: Gastroscope And Accessories, Flexible/Rigid
FDS is the FDA product code for gastroscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 79 510(k) submissions under FDS, 25 in the last five years, from 36 different applicants. The average 510(k) review took 147 days (median 134); 183 days on average over the last three years. FDA has posted 12 recalls for FDS devices, 5 initiated in the last five years.
Definition
To examine or perform procedures in the stomach. 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 | Gastroscope And Accessories, Flexible/Rigid |
| 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 FDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 258 |
| 2018 | 6 | 152 |
| 2019 | 5 | 140 |
| 2020 | 2 | 219 |
| 2021 | 5 | 103 |
| 2022 | 2 | 138 |
| 2023 | 3 | 135 |
| 2024 | 5 | 190 |
| 2025 | 8 | 184 |
| 2026 | 7 | 175 |
Compare with all 510(k) review times · Search every FDS clearance
Top FDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujifilm Corporation | 15 | 2026-02-17 |
| Pentax Precision Instrument Corp. | 7 | 2002-02-04 |
| Pentax of America, Inc. | 5 | 2025-12-16 |
| Fujinon, Inc. | 5 | 2012-08-13 |
| Olympus Medical Systems Corporation | 4 | 2026-08-27 |
31 more applicants have FDS clearances. See the full list in Caduvo.
Most recent FDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261400 | Ambu A/S | Ambu® aScope Gastro; Ambu® aScope Gastro Large | 2026-09-16 | 140 |
| K260824 | Olympus Medical Systems Corporation | Gastrointestinal Videoscope Olympus GIF-2T1500 | 2026-08-27 | 167 |
| K260856 | Olympus Medical Systems Corporation | Disposable Distal Attachment D-201-13404 | 2026-08-27 | 164 |
| K253702 | Intuitive Surgical, Inc. | Intuitive Endoluminal Gastrointestinal System (IG1000) | 2026-08-07 | 256 |
| K260573 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System | 2026-04-21 | 60 |
Recalls for FDS devices
12 product recalls in 10 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-10-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code FDS?
FDS is the FDA product code for gastroscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDS?
Across 79 cleared submissions the average was 147 days from receipt to decision (median 134).
Which companies have the most FDS clearances?
Fujifilm Corporation (15); Pentax Precision Instrument Corp. (7); Pentax of America, Inc. (5); Fujinon, Inc. (5); Olympus Medical Systems Corporation (4).
Have FDS devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2024-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code FDS
- Run a recall and safety report across every FDS manufacturer
- Watch product code FDS 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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