FDA 510(k)

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

Numéro K : K201832 · 2021-09-17

Date de décision2021-09-17

Code produitHET

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 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 2021-09-17 under 510(k) number K201832. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K201832.

When did Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 receive FDA 510(k) clearance?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 received FDA 510(k) clearance on 2021-09-17, under 510(k) number K201832.

Who is the listed applicant for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

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 Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

The FDA product code for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is HET.

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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 K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Dispositifs connexes (Code : HET)

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Source officielle

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