FDA product code OCU: Endoscopic Storage Cover
OCU is the FDA product code for endoscopic storage cover. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under OCU, from 6 different applicants. The average 510(k) review took 98 days (median 84). FDA has posted 1 recall for OCU devices, 1 initiated in the last five years.
Definition
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Storage Cover |
| 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 OCU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 21 |
| 2020 | 1 | 215 |
| 2021 | 1 | 161 |
Compare with all 510(k) review times · Search every OCU clearance
Top OCU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ga Health Company Limited | 1 | 2021-03-05 |
| STERIS Corporation | 1 | 2020-01-27 |
| Meditech Endoscopy, Ltd. | 1 | 2019-05-07 |
| Acmi Corporation | 1 | 2003-06-03 |
| United States Endoscopy Group, Inc. | 1 | 1995-04-06 |
1 more applicants have OCU clearances. See the full list in Caduvo.
Most recent OCU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202838 | Ga Health Company Limited | Andorate Universal Endoscope Tip Guard | 2021-03-05 | 161 |
| K191715 | STERIS Corporation | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | 2020-01-27 | 215 |
| K191011 | Meditech Endoscopy, Ltd. | Scope ProTech | 2019-05-07 | 21 |
| K030684 | Acmi Corporation | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | 2003-06-03 | 90 |
| K951104 | United States Endoscopy Group, Inc. | ENDOBOOT | 1995-04-06 | 27 |
Recalls for OCU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-12.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code OCU?
OCU is the FDA product code for endoscopic storage cover. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCU?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCU?
Across 6 cleared submissions the average was 98 days from receipt to decision (median 84).
Which companies have the most OCU clearances?
Ga Health Company Limited (1); STERIS Corporation (1); Meditech Endoscopy, Ltd. (1); Acmi Corporation (1); United States Endoscopy Group, Inc. (1).
Have OCU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2026-03-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OCU
- Run a recall and safety report across every OCU manufacturer
- Watch product code OCU 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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