510(k) clearances

HyperSuture Extension Line

Threadstone, LLC · General, Plastic Surgery

K234079Substantially EquivalentTraditionalGAT
Open FDA's page for this record
Third party flag
N
City
Millersville
Advisory committee description
General, Plastic Surgery
Address 1
1035 Benfield Blvd.
Address 2
Suite H
Statement or summary
Summary
Product code
GAT
Zip code
21108
Applicant
Threadstone, LLC
Decision date
2024-05-10
Decision code
SESE
Country code
US
Device name
HyperSuture Extension Line
Advisory committee
SU
Contact
Jeremy Clark
K number
K234079
State
MD
Date received
2023-12-22
Review advisory committee
SU
Postal code
21108
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Suture, Nonabsorbable, Synthetic, Polyethylene
Medical specialty description
General, Plastic Surgery
Regulation number
878.5000
Device class
2
Registration number
3005064037, 3012818475, 9616088, 3013668043, 3018094310, 3008868758, 3013298431, 1718850, 3005953126, 1062741, 3002579136, 3020954746, 3009018440, 3021008900, 3014479313, 3007319107, 3004192065, 3016926753, 3014276972, 3008837339, 1000484830, 9611459, 3005381997, 3022472578, 3019807891, 3005180920, 2244478, 3006630150, 3006946276, 3013302242, 3010060157, 3013767421, 1061124, 3016727307, 3006425876, 2521877, 2530154, 3006108336, 2090040, 1055236 +211 more
FEI number
3005064037, 3012818475, 3018094310, 3013668043, 1718850, 3008868758, 3013298431, 3005953126, 3002579136, 3020954746, 3009018440, 3021008900, 3014479313, 3007319107, 3004192065, 3016926753, 3014276972, 3008837339, 1000484830, 3005381997, 3022472578, 3019807891, 3005180920, 3006630150, 3006946276, 3013302242, 3010060157, 3006813973, 3016727307, 3013767421, 3002615969, 3006425876, 2521877, 3006108336, 3006981798, 3021632375, 3020983460, 3003139373, 3002807231, 3008483449 +211 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.