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# FDA Clears ‘Safer’ Pentax Duodenoscope
- URL: https://www.fdaweb.com/fda-clears-safer-pentax-duodenoscope/
- Published: 2019-11-15T12:00:00.000Z
- Updated: 2026-09-14T15:53:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145520

FDA has cleared a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will reduce the number of parts that need to be cleaned and disinfected in between uses. The Pentax Medical Video ED34-i10T2 is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.  

Preventing infections and assuring proper cleaning of duodenoscopes has been an agency priority over the past few years. During this period, a safety [communication](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktoemOev2-2FhQL9XDSYmnfhV2xApBoQ3Wnlm-2BnNasWNBHiW1RROdZZlTTDF9CH81tXVrJ88lGCq0uO7T2IM210hx79wex9pB-2BYP02FFx-2FAV9YndEL2O0qXLxRh-2FqSbEgclsDRMf3Xa7O3zIfqhI0fRZVP5UQIu2nONMEDMxRwLmVXsWIntncbLAwTZrdE6QcHSvNrIYlkhGKyRqpoDOfTwFAXWJmZ7832Fxn-2BmA4EEs8QyXTiAGBpddoVW5UyOHDRQqP4-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0Ru350ZHx8ePektuxXCIrzFrf0v8m-2FXX-2Fa0TEC9JhpC05imPiAvfUWK0irMlPVF6chF2TqHCLkypYbCqwz22BLKNRBZJ9g0-2B-2BI0LuMeifC9CzF3HrJ-2BaKvEfW5Wru6fPaD12ent6sRoaP9YZ6EovWXthWCPt4dO0QpFY6UZhYMv6y4GsmP8m1QtB37V1Dlvv-2Bgntj241koNsLZuwxmK2CKwNUrsZzR0rs8DavSB2T8eYKCR1bOB42jI0R9WPYBwY29YuyEe-2FN7Utbm6gtefo9-2FyK8G-2FG9MsYPVIoVxj5wu5NEo-3D&ref=fdaweb.com) was issued to health care facilities about following appropriate steps for cleaning and disinfecting these devices between use. In August, another [safety communication](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktoemOev2-2FhQL9XDSYmnfhV2xjynf1WWCMc7c781NI-2FZJysiwXqdaATJcEOFWywlGtOifZAlAricdl5OW-2Bjx1ikiWfd7VwQpk4oONHaC2UNbgcdkfER9v3H9rD-2FYHtizWcC-2F6EdWrquIyhz79W2r6Sk8SGB8bo1h5TqguYrP1xjbLhSvshW2JYeCyV-2FXYJIkOnCl0-2BBkxZ2aW65vVnHGATF04T6mYsHzrolyQQdQXBiwbM95bqh7XGxu7N9GGC4XMQbHsto-2Ftsb5vdFkh-2Fza4LKrhen39TVPdc9qGa9P-2BXED8ijBRP1r3VsP6WR-2Fr6r0J4Uw-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0Ru350ZHx8ePektuxXCIrzFrf0v8m-2FXX-2Fa0TEC9JhpC05imPiAvfUWK0irMlPVF6chF2TqHCLkypYbCqwz22BLKNRBZJ9g0-2B-2BI0LuMeifC9CzF3HrJ-2BaKvEfW5Wru6fPaD12ent6sRoaP9YZ6EovWXthdqJ0vvixmbJb19FloNC6g9fjhF1-2FVDjVpp46mXSg4jj-2FVj19I9fTr91eG9SdaTDDnRb-2BVL6mtJs-2FjGV04bkROTjaR99evARbURmFWZgqxNec7AIQwgt3e9UjNOpiji6gyQHEisdYmMPB2UF9yKAyBM-3D&ref=fdaweb.com) recommended that duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components.

An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-clears-first-duodenoscope-disposable-elevator-piece-reducing-number-parts-needing-disinfection?ref=fdaweb.com) notes that disposable designs can “simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination. The FDA has previously cleared duodenoscopes with removable endcap components. Today's clearance is the first device with a disposable elevator component — a part that has been traditionally difficult to clean and reprocess. The elevator part of the duodenoscope facilitates access to the bile and pancreatic ducts, and is used to position endoscopic instruments during the procedure.”