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# FDA Clears Revamped Pentax Duodenoscope
- URL: https://www.fdaweb.com/fda-clears-revamped-pentax-duodenoscope/
- Published: 2017-09-20T12:00:00.000Z
- Updated: 2026-09-14T22:51:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139675

FDA has cleared a Pentax of America 510(k) for the first duodenoscope with a disposable distal cap, a new feature that is intended to improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is indicated for use in visualizing and accessing to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. “We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” CDRH Office of Device Evaluation acting director **William Maisel** is quoted in a [release](http://www.marketwatch.com/story/fda-clears-first-duodenoscope-with-disposable-distal-cap-2017-09-20?ref=fdaweb.com) as saying. “Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

The new clearance is intended to address concerns raised earlier this year in a [safety communication](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537146.htm?ref=fdaweb.com) about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The alert identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope's distal cap onto the scope, which could allow fluids and tissue to leak into the duodenoscope.