FDA 510(k)

4K Camera Head OLYMPUS CH-S700-08-LB

Numéro K : K262079 · 2026-09-10

Date de décision2026-09-10

Code produitFET

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

4K Camera Head OLYMPUS CH-S700-08-LB 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 2026-09-10 under 510(k) number K262079. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 4K Camera Head OLYMPUS CH-S700-08-LB?

4K Camera Head OLYMPUS CH-S700-08-LB is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K262079.

When did 4K Camera Head OLYMPUS CH-S700-08-LB receive FDA 510(k) clearance?

4K Camera Head OLYMPUS CH-S700-08-LB received FDA 510(k) clearance on 2026-09-10, under 510(k) number K262079.

Who is the listed applicant for 4K Camera Head OLYMPUS CH-S700-08-LB?

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 4K Camera Head OLYMPUS CH-S700-08-LB?

The FDA product code for 4K Camera Head OLYMPUS CH-S700-08-LB is FET.

Essais cliniques associés

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

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)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 : FET)

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation K251734ProVee Video Processing Unit (PV-003)Proverum Limited K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation

Source officielle

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