FDA product code OAY: Light Source System, Diagnostic Endoscopic

OAY is the FDA product code for light source system, diagnostic endoscopic. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under OAY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for OAY devices.

Definition

A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.

Classification

Recalls for OAY devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-16.

Frequently asked questions

What is FDA product code OAY?

OAY is the FDA product code for light source system, diagnostic endoscopic. It is a Class III device, reviewed by the Gastroenterology and Urology panel.

What device class is OAY?

Class III. Typical premarket route: PMA.

Have OAY devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2012-08-16.

Next steps

• Run an FDA pathway report with predicate devices for product code OAY
• Run a recall and safety report across every OAY manufacturer
• Watch product code OAY 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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