Bronchoscope (Flexible or Rigid)

What Is This Device?

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code EOQ?

Bronchoscope (Flexible Or Rigid) is FDA product code EOQ, Class 2, 21 CFR 874.4680.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 23 clearances under this code; the FDA took a median of 172 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 160 recalls under this product code since 2011. 2 were by a company in China. 35 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (36), Labeling Change Control (16) and Process control (12). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.