510(k) clearances

MINT MONO Sutures

Hans Biomed Corporation · General, Plastic Surgery

K254238Substantially EquivalentTraditionalNEW
Open FDA's page for this record
Third party flag
N
City
Yuseong-Gu
Advisory committee description
General, Plastic Surgery
Address 1
64, Yuseong-Daero 1628 Beon-Gil
Statement or summary
Summary
Product code
NEW
Zip code
34054
Applicant
Hans Biomed Corporation
Decision date
2026-09-18
Decision code
SESE
Country code
KR
Device name
MINT MONO Sutures
Advisory committee
SU
Contact
Mark Bae
K number
K254238
Date received
2025-12-29
Review advisory committee
SU
Postal code
34054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Suture, Surgical, Absorbable, Polydioxanone
Medical specialty description
General, Plastic Surgery
Regulation number
878.4840
Device class
2
Registration number
1614993, 3010864832, 1221934, 3006680097, 2648650, 3007205024, 3010041511, 3010462274, 3015289316, 3030733800, 3004365956, 3016560306, 1064584, 3010692967, 3014615644, 3043226252, 3005953126, 3003828812, 2210968, 3013376016, 3007791599, 3006981798, 3006638824, 3011137372, 3014272734, 9617547, 3038138322, 3012494290, 2246552, 1221601, 3020983460, 3014579161, 3006562124, 3007895168, 3008912461, 3027329031, 3014461810, 1055236, 2125050, 3016244792 +47 more
FEI number
1614993, 1221934, 3006680097, 2648650, 3007205024, 3010862763, 3010041511, 3010462274, 3015289316, 3030733800, 3004365956, 3016560306, 1000112877, 3010692967, 3014615644, 3043226252, 3005953126, 3003828812, 2210968, 3013376016, 3007791599, 3006981798, 3006638824, 3014272734, 3038138322, 3012494290, 2246552, 1221601, 3020983460, 3014579161, 3006562124, 3007895168, 3008912461, 3027329031, 3014461810, 2125050, 3016244792, 3004117249, 3005972890, 3016904853 +47 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.