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Crownjun Nylon Suture

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K192420

by Kono Seisakusho Co., Ltd.

Identity

Trade Name
CROWNJUN Nylon Suture FDA UDI
Generic Name
Nylon suture, non-bioabsorbable, monofilament FDA UDI
Model / Reference
NDU00V-8 FDA UDI

Identifiers

Catalog Number
NDU00V-8 FDA UDI
Primary DI / UDI-DI
04946585260667 FDA UDI
510(k) Number
K192420 FDA 510(k)FDA UDI
FDA Product Code
GAR FDA 510(k)FDA UDI
GMDN Term
Nylon suture, non-bioabsorbable, monofilament FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.5020 FDA 510(k)
Regulation Number
878.5020 FDA 510(k)FDA UDI
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Crownjun Nylon Suture by Kono Seisakusho Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kono Seisakusho Co., Ltd.

Sources (2)

  • FDA 510(k) K192420 24 fields · synced Jun 18, 2026
  • FDA UDI c2c49890-03dc-491c-a37c-da5e07afff8e 34 fields · synced May 27, 2026