K-number	K253646
Device name	Single Use Distal Cover MAJ-2315 (MAJ-2315)
Applicant	Olympus Medical Systems Corp.
Product code	FDT
Device class	Class II
Decision date	Feb 22, 2026
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Single Use Distal Cover MAJ-2315 is a sterile, single-use accessory designed to attach to Olympus endoscopes to cover the distal end of the insertion tube and around the forceps elevator. It is used with the EVIS EXERA III Duodenoscope and is discarded after use.

Technological characteristics

The subject device is minimally changed from the predicate device (K220587), with changes limited to the addition of an Attachment Tool and a minor manufacturing process change. There are no changes to indications for use, conditions of use, compatible components, device design, or specifications for the MAJ-2315.

Test standards cited

Not stated in this summary. The document references verification/validation activities including performance testing (bench) and sterilization/shelf life testing, but does not cite specific consensus standards such as ISO, IEC, or ASTM.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Single Use Distal Cover MAJ-2315 (MAJ-2315)

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