510(k) clearances

NaturaJel™ Oral Wound Care Kit

HCS Innovation, LLC · Unknown

K260120Substantially EquivalentTraditionalOLR
Open FDA's page for this record
Third party flag
N
City
Union Grove
Advisory committee description
Unknown
Address 1
384 Highlands Ct.
Statement or summary
Summary
Product code
OLR
Zip code
35175
Applicant
HCS Innovation, LLC
Decision date
2026-08-05
Decision code
SESE
Country code
US
Device name
NaturaJel™ Oral Wound Care Kit
Contact
Ronnie Hanes
K number
K260120
State
AL
Date received
2026-01-15
Review advisory committee
DE
Postal code
35175
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Oral Wound Dressing
Medical specialty description
Unknown
Device class
U
Registration number
3016505723, 3004050854, 3012263097, 3010864832, 3029906643, 8043396, 3007735241, 3011276993, 3013576473, 3006497550, 3016096134, 3004146122, 2518467, 3004087544, 2938386, 3016611551, 2244725, 3005488444, 1450662, 3003311293, 1646434, 3004985762, 2032098, 3005488671, 3019867040, 3015528146, 3010143501, 2135339, 2032542, 9611959, 3006619672
FEI number
3016505723, 3004050854, 3012263097, 3003646540, 3029906643, 3010862763, 3007735241, 3011276993, 3013576473, 3006497550, 3003058448, 1000138377, 3016096134, 3004146122, 2518467, 3004087544, 2938386, 3016611551, 2244725, 3005488444, 1450662, 3003311293, 3004985762, 3002677549, 3005488671, 3019867040, 3007867940, 3015528146, 3005461046, 3010143501, 3006619672
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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.