V-Loc
Polybutester (PBT) Nonabsorbable Knotless Wound Closure Device
6manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| 510(k) | K111442 |
| Record published | 2015-09-02 |
| Record revised | 2025-10-09 (version 16) |
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 |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 12, case of 6 |
| Sizes | Length 4 to 18 in |
| Distribution end date | 2026-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VLOCN208L | diameter,2/0,N/A; | In distribution |
| VLOCN008L | Length 8 in | In distribution |
| VLOCN0615 | Length 12 in | In distribution |
| VLOCN0437 | diameter, 1, N/A; | In distribution |
| VLOCN006L | diameter,0,N/A; | In distribution |
| VLOCN0604 | Diameter,3/0,N/A; | In distribution |
| VLOCN0644 | Diameter,3/0,N/A; | In distribution |
| VLOCN0605 | Diameter,2/0,N/A; | In distribution |
| VLOCN308L | Length 8 in | In distribution |
| VLOCN0305 | Diameter,2/0,N/A; | In distribution |
| VLOCN0306 | Diameter,0,N/A; | In distribution |
| VLOCN0614 | Length 12 in | In distribution |
| VLOCN0325 | Diameter,2/0,N/A; | In distribution |
| VLOCN306L | Length 6 in | In distribution |
| VLOCN0804 | diameter,3/0,N/A; | In distribution |
| VLOCN1126 | Diameter,0,N/A; | In distribution |
| VLOCN0327 | Length 18 in | In distribution |
| VLOCN0814 | Diameter,3/0,N/A; | In distribution |
| VLOCN0326 | Diameter,0,N/A; | In distribution |
| VLOCN206L | Length 6 in | In distribution |
| VLOCN0014 | Diameter,3/0,N/A; | Withdrawn |
| VLOCN304L | Length 4 in | Withdrawn |
| VLOCN0824 | Diameter,3/0,N/A; | Withdrawn |
| VLOCN1125 | Length 18 in | Withdrawn |
| VLOCN204L | Length 4 in | Withdrawn |
| VLOCN0624 | Diameter,3/0,N/A; | Withdrawn |
| VLOCN004L | diameter,0,N/A; | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2022-09-28 | Class II | Process control | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allerg | 30658 |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | 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.