FDA product code GCW: Transformer, Endoscope

GCW is the FDA product code for transformer, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under GCW. The average 510(k) review took 50 days (median 50). FDA has posted 6 recalls for GCW devices.

Classification

Compare with all 510(k) review times · Search every GCW clearance

Top GCW applicants

Most recent GCW clearances

Recalls for GCW devices

6 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-13.

Frequently asked questions

What is FDA product code GCW?

GCW is the FDA product code for transformer, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.

What device class is GCW?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code GCW?

Across 1 cleared submissions the average was 50 days from receipt to decision (median 50).

Which companies have the most GCW clearances?

Welch Allyn, Inc. (1).

Have GCW devices been recalled?

Yes: 6 product recalls across 2 recall events; the most recent began 2017-04-13.

Next steps

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