FDA product code OCY: Endoscopic Guidewire, Gastroenterology-Urology
OCY is the FDA product code for endoscopic guidewire, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 43 510(k) submissions under OCY, from 25 different applicants. The average 510(k) review took 77 days (median 57). FDA has posted 10 recalls for OCY devices, 1 initiated in the last five years.
Definition
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Guidewire, Gastroenterology-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OCY clearance
Top OCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 5 | 2014-11-05 |
| Boston Scientific Corp | 5 | 2014-10-21 |
| Lake Region Medical | 4 | 2014-09-19 |
| Neometrics, Inc. | 3 | 2015-03-16 |
| Coloplast A/S | 2 | 2015-05-27 |
20 more applicants have OCY clearances. See the full list in Caduvo.
Most recent OCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153264 | Medi-Globe Corporation | EasyPass Guidewire | 2016-05-19 | 189 |
| K151471 | Terumo Medical Corporation | Radifocus Glidewire Endoscopic Wire | 2015-09-17 | 108 |
| K150927 | Coloplast A/S | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | 2015-05-27 | 51 |
| K150225 | Neometrics, Inc. | NovaGold High Performance Guidewire | 2015-03-16 | 42 |
| K142950 | Wilson-Cook Medical, Inc. | Acrobat Calibrated Tip Wire Guide | 2014-11-05 | 26 |
Recalls for OCY devices
10 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-16.
| Year | Recalls |
|---|---|
| 2019 | 8 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code OCY?
OCY is the FDA product code for endoscopic guidewire, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCY?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OCY?
Across 43 cleared submissions the average was 77 days from receipt to decision (median 57).
Which companies have the most OCY clearances?
Wilson-Cook Medical, Inc. (5); Boston Scientific Corp (5); Lake Region Medical (4); Neometrics, Inc. (3); Coloplast A/S (2).
Have OCY devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2022-08-16.
Next steps
- Run an FDA pathway report with predicate devices for product code OCY
- Run a recall and safety report across every OCY manufacturer
- Watch product code OCY 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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