FDA product code OCV: Endoscope Holder
OCV is the FDA product code for endoscope holder. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under OCV, 2 in the last five years, from 9 different applicants. The average 510(k) review took 138 days (median 77); 252 days on average over the last three years.
Definition
To hold endoscope in a desired position during procedures.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope Holder |
| 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 OCV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 91 |
| 2024 | 2 | 252 |
Compare with all 510(k) review times · Search every OCV clearance
Top OCV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carefusion 2200 | 2 | 2010-12-02 |
| Karl Storz Endoscopy America, Inc. | 1 | 2024-10-22 |
| Aktormed GmbH | 1 | 2024-04-25 |
| Biomet Microfixation | 1 | 2019-06-05 |
| Integra Neurocare, LLC | 1 | 1999-08-17 |
4 more applicants have OCV clearances. See the full list in Caduvo.
Most recent OCV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240506 | Karl Storz Endoscopy America, Inc. | KARL STORZ Holders | 2024-10-22 | 244 |
| K232405 | Aktormed GmbH | ENDOFIX EXO | 2024-04-25 | 259 |
| K190576 | Biomet Microfixation | WalterLorenz Surgical Assist Arm Scope Holder | 2019-06-05 | 91 |
| K102179 | Carefusion 2200 | ENVIEW (TM) | 2010-12-02 | 121 |
| K093616 | Carefusion 2200 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | 2009-12-23 | 34 |
Recalls for OCV devices
openFDA lists no recalls for product code OCV.
Frequently asked questions
What is FDA product code OCV?
OCV is the FDA product code for endoscope holder. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCV?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCV?
Across 10 cleared submissions the average was 138 days from receipt to decision (median 77).
Which companies have the most OCV clearances?
Carefusion 2200 (2); Karl Storz Endoscopy America, Inc. (1); Aktormed GmbH (1); Biomet Microfixation (1); Integra Neurocare, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OCV
- Run a recall and safety report across every OCV manufacturer
- Watch product code OCV 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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