FDA product code FDF: Colonoscope And Accessories, Flexible/Rigid
FDF is the FDA product code for colonoscope 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 115 510(k) submissions under FDF, 22 in the last five years, from 56 different applicants. The average 510(k) review took 131 days (median 99); 154 days on average over the last three years. FDA has posted 25 recalls for FDF devices, 12 initiated in the last five years.
Definition
To examine or perform procedures in the colon or rectum 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 | Colonoscope 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 FDF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 88 |
| 2018 | 7 | 124 |
| 2019 | 4 | 102 |
| 2020 | 4 | 214 |
| 2021 | 3 | 64 |
| 2022 | 5 | 189 |
| 2023 | 6 | 189 |
| 2024 | 2 | 140 |
| 2025 | 4 | 186 |
| 2026 | 5 | 136 |
Compare with all 510(k) review times · Search every FDF clearance
Top FDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax Precision Instrument Corp. | 11 | 1996-06-24 |
| Motus GI Medical Technologies , Ltd. | 7 | 2023-10-20 |
| Lumendi, LLC | 6 | 2023-02-10 |
| Avantis Medical Systems, Inc. | 6 | 2016-05-17 |
| Fujifilm Corporation | 5 | 2025-05-23 |
51 more applicants have FDF clearances. See the full list in Caduvo.
Most recent FDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260503 | Neptune Medical, Inc. | Triton 1 System | 2026-09-03 | 198 |
| K261015 | Gi View, Ltd. | Solo Scope Colonoscope System | 2026-08-21 | 147 |
| K261587 | BPEndo, LLC | Insufflation Retention Device (IRD) (11173-325-101) | 2026-07-02 | 50 |
| K260423 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Disposable Endoscopic Distal Attachments | 2026-05-28 | 108 |
| K252457 | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Disposable Distal End Tape Hood | 2026-01-30 | 178 |
Recalls for FDF devices
25 product recalls in 15 recall events; 12 initiated in the last five years and 13 still open. Most recent: 2024-01-11.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 3 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 8 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code FDF?
FDF is the FDA product code for colonoscope 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 FDF?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDF?
Across 115 cleared submissions the average was 131 days from receipt to decision (median 99).
Which companies have the most FDF clearances?
Pentax Precision Instrument Corp. (11); Motus GI Medical Technologies , Ltd. (7); Lumendi, LLC (6); Avantis Medical Systems, Inc. (6); Fujifilm Corporation (5).
Have FDF devices been recalled?
Yes: 25 product recalls across 15 recall events; the most recent began 2024-01-11.
Next steps
- Run an FDA pathway report with predicate devices for product code FDF
- Run a recall and safety report across every FDF manufacturer
- Watch product code FDF 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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