510(k) clearances

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)

Guangzhou Red Pine Medical Instrument Co., Ltd. · Gastroenterology, Urology

K262488Substantially EquivalentTraditionalFGB
Open FDA's page for this record
Third party flag
N
City
Guangzhou
Advisory committee description
Gastroenterology, Urology
Address 1
12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H
Statement or summary
Summary
Product code
FGB
Zip code
510000
Applicant
Guangzhou Red Pine Medical Instrument Co., Ltd.
Decision date
2026-09-09
Decision code
SESE
Country code
CN
Device name
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Advisory committee
GU
Contact
Weihua Yang
K number
K262488
Date received
2026-07-20
Review advisory committee
GU
Postal code
510000
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
3017425975, 8043903, 3014683069, 3013992977, 3013247477, 3017210488, 3005580113, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 9616693, 3021246306, 3004040397, 3004111573, 3014644276, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 2531475, 3017367014, 3012843412, 3015139943, 3003206812, 9610773, 3008776287, 3042940358, 3002808148, 9610595 +81 more
FEI number
3014683069, 3013992977, 3002808273, 3013247477, 3017210488, 3005580113, 3003922255, 3011986317, 3032959393, 3014893827, 3010220595, 1000121056, 3012797688, 3021246306, 3008185830, 3004040397, 3004111573, 1418479, 1820334, 3010421104, 3021031769, 3025349506, 3032429484, 3022106566, 3012322232, 3020746799, 3037966040, 2936485, 3004361445, 3017367014, 3006149253, 3015139943, 3012843412, 3003206812, 3006759904, 3008776287, 3002808268, 3007475226, 3002806565, 3002808148 +81 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.