510(k) clearances

F88 URE-SD/RD Flexible Ureteroscope

Sg Endoscopy Pte, Ltd. · Gastroenterology, Urology

K243894Substantially EquivalentTraditionalFGB
Open FDA's page for this record
Third party flag
N
City
N/A
Advisory committee description
Gastroenterology, Urology
Address 1
79 Loyang Way
Statement or summary
Summary
Product code
FGB
Zip code
508766
Applicant
Sg Endoscopy Pte, Ltd.
Decision date
2025-05-02
Decision code
SESE
Country code
SG
Device name
F88 URE-SD/RD Flexible Ureteroscope
Advisory committee
GU
Contact
John Yeng Jie Woo
K number
K243894
Date received
2024-12-18
Review advisory committee
GU
Postal code
508766
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Ureteroscope And Accessories, Flexible/Rigid
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3008776287, 3021031769, 8043903, 3016045249, 3016690337, 3012322232, 1319639, 1828132, 3017961114, 1000121056, 3014683069, 1220477, 3015540957, 8010047, 1000484830, 1037955, 3015925378, 3025318945, 3011050570, 3005580113, 3029929134, 3004644065, 3024021261, 3002807314, 3011642792, 3014893827, 9610773, 3004040397, 3012797688, 3029981244, 9611612, 3014615697, 3010419931, 3000160970, 3011986317, 9614434, 3014342096, 9610595, 3021246306, 3012375451 +80 more
FEI number
3008776287, 3021031769, 3016045249, 3016690337, 3012322232, 3002807798, 1828132, 3017961114, 1000121056, 3014683069, 1220477, 3007130719, 3015540957, 1037955, 1000484830, 3015925378, 3025318945, 3011050570, 3005580113, 1000138054, 3029929134, 3002964398, 3004644065, 3024021261, 3002807314, 3000206435, 3011642792, 3014893827, 3002808268, 3004040397, 3012797688, 3001642379, 3008185830, 3029981244, 3002808001, 3014615697, 3010419931, 3002806565, 3002807111, 3000160970 +80 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.