510(k) clearances

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

Olympus Medical Systems Corp. · Gastroenterology, Urology

K262079Substantially EquivalentTraditionalFET
Open FDA's page for this record
Third party flag
N
City
Tokyo
Advisory committee description
Gastroenterology, Urology
Address 1
2951 Ishikawa-Cho
Address 2
Hachioji-Shi
Statement or summary
Summary
Product code
FET
Zip code
192-8507
Applicant
Olympus Medical Systems Corp.
Decision date
2026-09-10
Decision code
SESE
Country code
JP
Device name
4K Camera Head OLYMPUS CH-S700-08-LB
Advisory committee
GU
Contact
Seiko Yunoki
K number
K262079
Date received
2026-06-22
Review advisory committee
SU
Postal code
192-8507
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
8043903, 3013247477, 2431166, 3010220595, 1000121056, 3012797688, 3021246306, 3004040397, 3014644276, 3001722928, 3015612252, 3010885402, 3022106566, 3007305485, 3012322232, 3020746799, 3041659934, 2936485, 3015531529, 3012843412, 3044186618, 3010398867, 9610773, 3016762717, 3015807001, 3002808148, 9610595, 3010202439, 9610612, 3003782610, 3010273872, 3033010858, 1643264, 3014342096, 3011050570, 2183570, 3003018722, 3036978610, 8010298, 3016832577 +51 more
FEI number
3002806315, 3002808273, 3013247477, 3010220595, 1000121056, 3012797688, 3021246306, 3008185830, 3004040397, 3001722928, 3015612252, 3010885402, 3022106566, 3007305485, 3012322232, 3020746799, 3041659934, 2936485, 3015531529, 3006149253, 3012843412, 3044186618, 3010398867, 3016762717, 3006759904, 3002808268, 3015807001, 3007475226, 3002806565, 3002808148, 3003448211, 3003782610, 3002807795, 3002808088, 3010273872, 3033010858, 1643264, 3014342096, 3002808127, 3011050570 +51 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.