FDA 510(k)

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

K-번호: K201832 · 2021-09-17

결정일2021-09-17

제품 코드HET

자문 위원회OB

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Olympus Medical Systems Corp.를 신청인으로 등재한 기타 기록

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, 전동식 잡이형 S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, 전동식 잡이형 S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, 전동식 잡이형 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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