Crownjun Nylon Suture
Crownjun Nylon Suture is a sterile, nonabsorbable monofilament used to join soft-tissue wound edges or ligate soft tissue. A pre-attached needle carries the strand through tissue, where the…
Crownjun Nylon Suture is a sterile, nonabsorbable monofilament used to join soft-tissue wound edges or ligate soft tissue. A pre-attached needle carries the strand through tissue, where the nylon strand provides the mechanical connection.
The strand is made from polyamide 6,6 and is available undyed or black-dyed. It remains nonabsorbable, while the supplied needle is made from 300-series stainless steel.
Listed Item
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.
Strand and Needle Choices
The range covers USP sizes from 12-0 through 0 and strand lengths from 2.5 to 90 cm. Needle tip shapes, curvatures and sizes also vary, so each model combines a strand specification with a particular needle geometry.
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Kono Seisakusho, Japan |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K192420 |
| Record published | 2026-03-12 |
| Record revised | 2021-04-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS-01V | In distribution | |
| NNUG00V-5-N | In distribution | |
| NDYG019-5-N | In distribution | |
| NDWG02V-5-N | In distribution | |
| NNLG00V-5-N | In distribution | |
| NDD013B | In distribution | |
| MS-03X | In distribution | |
| ND217 | In distribution | |
| NNUG01V-5-N | In distribution | |
| MS-01Y | In distribution | |
| NDM01X | In distribution | |
| NDO528S5 | In distribution | |
| NDL00W-7 | In distribution | |
| MS-00W | In distribution | |
| NDU00V-8 | In distribution | |
| NDD017B | In distribution | |
| MS-018 | In distribution | |
| NDY00V | In distribution | |
| NDWG01V-5-N | In distribution | |
| MS-008 | In distribution | |
| NDM00X-7 | In distribution | |
| NDLG00W | In distribution | |
| MS-01W | In distribution | |
| NBB013B | In distribution | |
| NDU01V | In distribution | |
| NDUG00W-5-N | In distribution | |
| NDY019-25 | In distribution | |
| NNWG03V-5-N | In distribution | |
| NDH01Y | In distribution | |
| NNLG01V-5-N | In distribution | |
| NBB024B | In distribution | |
| NCM00X | In distribution | |
| NDWG00V-5-N | In distribution | |
| MS-009 | In distribution | |
| NDZ00Y | In distribution | |
| NDUG00W-7 | In distribution | |
| NCU01V | In distribution | |
| NCU00W | In distribution | |
| NDLG00W-7 | In distribution | |
| MS-019 | In distribution | |
| MS-02X | In distribution | |
| NDH00Y | In distribution | |
| NDO008 | In distribution | |
| MS-00X | In distribution | |
| MS-00V | In distribution | |
| MS-01X | In distribution | |
| NDUG00V | In distribution | |
| NSWG01V-5-N | In distribution | |
| NDU00W | In distribution | |
| NNWG00V-5-N | In distribution | |
| NSWG00V-5-N | In distribution | |
| NDUG00W | In distribution | |
| NNWG02V-5-N | In distribution | |
| NDD024B | In distribution | |
| NDOKA8 | In distribution | |
| MS-00Y | In distribution | |
| NNYG009-5-N | In distribution | |
| N-SET002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| Monosof | Covidien LP | 256 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 127 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192420 | 2020-05-29 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.