510(k) clearances

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

Ushare Medical, Inc. · Unknown

K240097Substantially EquivalentTraditionalQSY
Open FDA's page for this record
Third party flag
N
City
Zhuhai
Advisory committee description
Unknown
Address 1
#445, Anji Zhong Rd.,Sanzao Town
Statement or summary
Summary
Product code
QSY
Zip code
519040
Applicant
Ushare Medical, Inc.
Decision date
2024-05-22
Decision code
SESE
Country code
CN
Device name
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
Contact
Yun Chen
K number
K240097
Date received
2024-01-12
Review advisory committee
SU
Postal code
519040
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Medical specialty description
Unknown
Device class
U
Registration number
3011657181, 8021832, 2183319, 3005818605, 3010256218, 9617592, 3026322855, 1061124, 3008298053, 9611590, 3006619672, 3015219237, 3001186500, 3012777736, 1120890, 3010864832, 3004111573, 3033589330, 3011137372, 3034735187, 3015422337, 3002807310, 3006260740, 3004740112, 3006324197, 9680794, 1625425, 3011400126, 3011088743, 3031288561, 1223089, 3003767891, 8043396, 3010878315, 1417592, 3010155661, 3025413691, 3027815, 3016844359, 3007663067 +80 more
FEI number
3011657181, 3004728227, 2183319, 3005818605, 3010256218, 3026322855, 3008298053, 3006619672, 3015219237, 3001186500, 3012777736, 1120890, 3003015552, 3008162665, 3004111573, 3033589330, 3034735187, 3015422337, 3002565916, 3002807310, 3006260740, 3004740112, 3006324197, 1625425, 3011400126, 3011088743, 1000237915, 1000120505, 3031288561, 3003767891, 3010878315, 1417592, 3010155661, 3025413691, 3016844359, 3007663067, 3003737899, 3015225571, 3002807112, 3010123105 +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.