FDA 510(k)

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

Numéro K : K253646 · 2026-02-22

Date de décision2026-02-22

Code produitFDT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Single Use Distal Cover MAJ-2315 (MAJ-2315) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2026-02-22 under 510(k) number K253646. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Single Use Distal Cover MAJ-2315 (MAJ-2315)?

Single Use Distal Cover MAJ-2315 (MAJ-2315) is a medical device that received FDA 510(k) clearance on 2026-02-22. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K253646.

When did Single Use Distal Cover MAJ-2315 (MAJ-2315) receive FDA 510(k) clearance?

Single Use Distal Cover MAJ-2315 (MAJ-2315) received FDA 510(k) clearance on 2026-02-22, under 510(k) number K253646.

Who is the listed applicant for Single Use Distal Cover MAJ-2315 (MAJ-2315)?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Distal Cover MAJ-2315 (MAJ-2315)?

The FDA product code for Single Use Distal Cover MAJ-2315 (MAJ-2315) is FDT.

Essais cliniques associés

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Autres dossiers indiquant Olympus Medical Systems Corp. en tant que demandeur

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Poignée actionnée à l'avant Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Poignée actionnée à l'avant Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Poignée actionnée à l'avant Type S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)

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Dispositifs connexes (Code : FDT)

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.

Source officielle

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