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FDA 510(k)

HD Camera Head OLYMPUS CH-S200-08-LB

K-Number: K261260 · 2026-06-24

ApplicantOlympus Medical Systems Corporation
Decision Date2026-06-24
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD Camera Head OLYMPUS CH-S200-08-LB is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K261260. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD Camera Head OLYMPUS CH-S200-08-LB?

HD Camera Head OLYMPUS CH-S200-08-LB is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K261260.

When did HD Camera Head OLYMPUS CH-S200-08-LB receive FDA 510(k) clearance?

HD Camera Head OLYMPUS CH-S200-08-LB received FDA 510(k) clearance on 2026-06-24, under 510(k) number K261260.

Who is the listed applicant for HD Camera Head OLYMPUS CH-S200-08-LB?

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

What is the FDA product code for HD Camera Head OLYMPUS CH-S200-08-LB?

The FDA product code for HD Camera Head OLYMPUS CH-S200-08-LB is FET.

Other records listing Olympus Medical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip 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)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DK251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

View all 112 devices →

Related Devices (Code: FET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm CorporationK242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAOlympus Corporations of the Americas

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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