FDA product code OCX: Endoscopic Irrigation/Suction System
OCX is the FDA product code for endoscopic irrigation/suction system. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 93 510(k) submissions under OCX, 21 in the last five years, from 55 different applicants. The average 510(k) review took 117 days (median 88); 140 days on average over the last three years. FDA has posted 18 recalls for OCX devices, 4 initiated in the last five years.
Definition
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Irrigation/Suction System |
| 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 OCX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 5 | 107 |
| 2019 | 8 | 172 |
| 2020 | 4 | 91 |
| 2021 | 3 | 239 |
| 2022 | 6 | 101 |
| 2023 | 7 | 141 |
| 2024 | 4 | 98 |
| 2025 | 4 | 182 |
Compare with all 510(k) review times · Search every OCX clearance
Top OCX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ga Health Company Limited | 6 | 2023-08-01 |
| Erbe USA, Inc. | 6 | 2022-08-11 |
| Byrne Medical, Inc. | 5 | 2012-04-27 |
| Endochoice, Inc. | 4 | 2016-05-26 |
| United States Endoscopy Group, Inc. | 4 | 2014-04-04 |
50 more applicants have OCX clearances. See the full list in Caduvo.
Most recent OCX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251986 | Olympus Medical Systems Corporation | AUXILIARY WATER TUBE MAJ-855 | 2025-09-26 | 91 |
| K251997 | Olympus Medical Systems Corporation | Single-Use Biopsy Valve (MAJ-1555) | 2025-09-25 | 90 |
| K242586 | Ovesco Endoscopy AG | ArgoCap (200.52) | 2025-05-22 | 265 |
| K241704 | Hangzhou AGS MedTech Co., Ltd. | Endoscopic Water Pump | 2025-03-20 | 280 |
| K242357 | Olympus Medical Systems Corporation | Water Container (MAJ-901); Water Container (MAJ-902) | 2024-10-07 | 60 |
Recalls for OCX devices
18 product recalls in 6 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-03-31.
| Year | Recalls |
|---|---|
| 2020 | 11 |
| 2022 | 2 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code OCX?
OCX is the FDA product code for endoscopic irrigation/suction system. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCX?
Across 93 cleared submissions the average was 117 days from receipt to decision (median 88).
Which companies have the most OCX clearances?
Ga Health Company Limited (6); Erbe USA, Inc. (6); Byrne Medical, Inc. (5); Endochoice, Inc. (4); United States Endoscopy Group, Inc. (4).
Have OCX devices been recalled?
Yes: 18 product recalls across 6 recall events; the most recent began 2026-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code OCX
- Run a recall and safety report across every OCX manufacturer
- Watch product code OCX 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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