OCXClass II
Endoscopic Irrigation/Suction System
21 CFR 876.1500 / Gastroenterology, Urology
OCX is the FDA product code for Endoscopic Irrigation/Suction System, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures". As of , FDA records hold 93 510(k) clearances under this code, the most recent dated , and 18 recalls.
Classification record
- Product code
- OCX
- Device name
- Endoscopic Irrigation/Suction System
- FDA definition
- To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 93
- Ingested recalls
- 18
Clearances, product code OCX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 3 |
| 2014 | 6 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 5 |
| 2019 | 8 |
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 6 |
| 2023 | 7 |
| 2024 | 4 |
| 2025 | 4 |
Applicants with the most clearances
Product code OCX| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 6 |
| Erbe USA Inc | 6 |
| GA Health Company Limited | 6 |
| Byrne Medical, Inc. | 5 |
| Karl Storz Endoscopy-America, Inc. | 4 |
| United States Endoscopy Group, Inc. | 4 |
| Hobbs Medical, Inc. | 3 |
| Olympus Medical Systems Corp. | 3 |
| Smartdata Suzhou Co., Ltd | 3 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acteon, Inc.
- Aizu Olympus Co., Ltd.
- Algram Group Ltd
- Andersen Caledonia Ltd
- Biotex, Inc.
- Boston Scientific Corporation
- C.R. Bard Inc
- CEA Global Dominicana d.b.a. Nissha Medical Technologies
- Changzhou Endoclean Medical Device Co., Ltd.
- Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
- Chongqing Jinshan Science & Technology (Group) Co., Ltd
- Cipher Surgical Ltd
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.