FDA.reportPublic FDA data

CROWNJUN Nylon Suture

Primary DI
04946585362309
Brand
CROWNJUN Nylon Suture
Company
KONO SEISAKUSHO CO.,LTD.
Model
MS-009
Device description
CROWNJUN Nylon Suture is a sterile, monofilament, synthetic, non-bioabsorbable suture made of nylon. CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues. See device description included in 510(k) application.
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192420000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192420000Crownjun Nylon SutureKono Seisakusho Co., Ltd.2020-05-29GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14946585362306PackageGS112In Commercial Distribution
04946585362309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494658536230614946585362306
04946585362309049465853623094946585362309

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Regulatory Flags#

DUNS number
691486468
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946585362286CROWNJUN Nylon SutureMS-0082026-03-12
04946585362293CROWNJUN Nylon SutureMS-0182026-03-12
04946585362316CROWNJUN Nylon SutureMS-0192026-03-12
04946585362323CROWNJUN Nylon SutureMS-00V2026-03-12
04946585362330CROWNJUN Nylon SutureMS-01V2026-03-12
04946585362347CROWNJUN Nylon SutureMS-00W2026-03-12
04946585362354CROWNJUN Nylon SutureMS-01W2026-03-12
04946585362361CROWNJUN Nylon SutureMS-00X2026-03-12
04946585362378CROWNJUN Nylon SutureMS-01X2026-03-12
04946585362385CROWNJUN Nylon SutureMS-02X2026-03-12
04946585362392CROWNJUN Nylon SutureMS-03X2026-03-12
04946585362408CROWNJUN Nylon SutureMS-00Y2026-03-12
04946585362415CROWNJUN Nylon SutureMS-01Y2026-03-12
14946585362283CROWNJUN Nylon SutureMS-0082026-03-12
14946585362290CROWNJUN Nylon SutureMS-0182026-03-12
14946585362306CROWNJUN Nylon SutureMS-0092026-03-12
14946585362313CROWNJUN Nylon SutureMS-0192026-03-12
14946585362320CROWNJUN Nylon SutureMS-00V2026-03-12
14946585362337CROWNJUN Nylon SutureMS-01V2026-03-12
14946585362344CROWNJUN Nylon SutureMS-00W2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031088054ETHILONETHICON, LLCGAR2026-07-03
10705031089600ETHILONETHICON, LLCGAR2026-07-03
10705031097018ETHILONETHICON, LLCGAR2026-07-03
10705031099975ETHILONETHICON, LLCGAR2026-07-03
07757093013747SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013891SUTUMEDUnilene S.A.C.GAR2024-09-19
07757093013068SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013280SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013563SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013587SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013600SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013877SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093013952SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014041SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014096SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014188SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014362SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014393SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014560SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014713SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014744SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014768SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014881SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014898SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093014911SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015048SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015093SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015147SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015253SUTUMEDUnilene S.A.C.GAR2023-01-06
07757093015277SUTUMEDUnilene S.A.C.GAR2023-01-06