FDA.reportPublic FDA data

CROWNJUN Nylon Suture

Primary DI
14946585348492
Brand
CROWNJUN Nylon Suture
Company
KONO SEISAKUSHO CO.,LTD.
Model
NNYG009-5-N
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
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14946585348492PackageGS112In Commercial Distribution
04946585348495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494658534849214946585348492
04946585348495049465853484954946585348495

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691486468
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946585362286CROWNJUN Nylon SutureMS-0082026-03-12
04946585362293CROWNJUN Nylon SutureMS-0182026-03-12
04946585362309CROWNJUN Nylon SutureMS-0092026-03-12
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

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