FDA 510(k)

Disposable Grasping Forceps FG-52D/FG-54D

K-번호: K250263 · 2025-03-31

결정일2025-03-31

제품 코드KTI

자문 위원회EN

결정Substantially Equivalent

기기 요약

Disposable Grasping Forceps FG-52D/FG-54D 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 2025-03-31 under 510(k) number K250263. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Disposable Grasping Forceps FG-52D/FG-54D?

Disposable Grasping Forceps FG-52D/FG-54D is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K250263.

When did Disposable Grasping Forceps FG-52D/FG-54D receive FDA 510(k) clearance?

Disposable Grasping Forceps FG-52D/FG-54D received FDA 510(k) clearance on 2025-03-31, under 510(k) number K250263.

Who is the listed applicant for Disposable Grasping Forceps FG-52D/FG-54D?

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 Disposable Grasping Forceps FG-52D/FG-54D?

The FDA product code for Disposable Grasping Forceps FG-52D/FG-54D is KTI.

Olympus Medical Systems Corp.를 신청인으로 등재한 기타 기록

K2620794K 캠에어 헤드 올림푸스 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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