V-Loc 180
Absorbable Wound Closure Device, HOS-12, 1x Green Strand
4manufacturers in China registered for this device type
81catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| 510(k) | K091087 |
| Record published | 2015-09-02 |
| Record revised | 2025-10-16 (version 32) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| 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 24 in |
| Distribution end date | 2026-02-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VLOCL0004 | Diameter,3/0,N/A; | In distribution |
| VLOCA308L | Length 8 in | In distribution |
| VLOCL2836 | diameter, 0, N/A; | In distribution |
| VLOCA006L | Length 6 in | In distribution |
| VLOCL1544 | Diameter,3/0,N/A; | In distribution |
| VLOCL0813 | Diameter,4/0,N/A; | In distribution |
| VLOCL0306 | Diameter,0,N/A; | In distribution |
| VLOCL2145 | Diameter,2/0,N/A; | In distribution |
| VLOCA206L | Length 6 in | In distribution |
| VLOCL2825 | Length 18 in | In distribution |
| VLOCL0335 | Diameter,2/0,N/A; | In distribution |
| VLOCL0624 | Length 18 in | In distribution |
| VLOCL1545 | Length 9 in | In distribution |
| VLOCL0315 | Diameter,2/0,N/A; | In distribution |
| VLOCL0814 | Length 12 in | In distribution |
| VLOCL0344 | Length 9 in | In distribution |
| VLOCL0613 | Diameter,4/0,N/A; | In distribution |
| VLOCA008L | Length 8 in | In distribution |
| VLOCL0125 | Diameter,2/0,N/A; | In distribution |
| VLOCL0034 | Diameter,3/0,N/A; | In distribution |
| VLOCL0133 | Length 23 in | In distribution |
| VLOCL0033 | Diameter,4/0,N/A; | In distribution |
| VLOCL0025 | Diameter,2/0,N/A; | In distribution |
| VLOCL3216 | diameter, 0, N/A; | In distribution |
| VLOCL2744 | Diameter,3/0,N/A; | In distribution |
| VLOCL0115 | Diameter,2/0,N/A; | In distribution |
| VLOCL0336 | Length 24 in | In distribution |
| VLOCL0614 | Diameter,3/0,N/A; | In distribution |
| VLOCL0625 | Diameter,2/0,N/A; | In distribution |
| VLOCL0023 | diameter,4/0,N/A; | In distribution |
| VLOCL2105 | Diameter,2/0,N/A; | In distribution |
| VLOCL0114 | Diameter,3/0,N/A; | In distribution |
| VLOCL2826 | Length 18 in | In distribution |
| VLOCL1413 | Diameter,4/0,N/A; | In distribution |
| VLOCL0345 | Diameter,2/0,N/A; | In distribution |
| VLOCL0224 | Length 18 in | In distribution |
| VLOCL0324 | Length 18 in | In distribution |
| VLOCL0436 | diameter,0,N/A; | In distribution |
| VLOCL0223 | Diameter,4/0,N/A; | In distribution |
| VLOCL0615 | Diameter,2/0,N/A; | In distribution |
| VLOCL0014 | Diameter,3/0,N/A; | In distribution |
| VLOCL0325 | Diameter,2/0,N/A; | In distribution |
| VLOCL4636 | diameter, 0, N/A; | In distribution |
| VLOCL0134 | diameter,3/0,N/A; | In distribution |
| VLOCL0803 | Length 6 in | In distribution |
| VLOCL0804 | Diameter,3/0,N/A; | In distribution |
| VLOCL0013 | Diameter,4/0,N/A; | In distribution |
| VLOCL2815 | Diameter,2/0,N/A; | In distribution |
| VLOCL0603 | Length 6 in | In distribution |
| VLOCL0426 | Length 18 in | In distribution |
| VLOCL0844 | Length 9 in | In distribution |
| VLOCL0024 | Diameter,3/0,N/A; | In distribution |
| VLOCL0123 | Diameter,4/0,N/A; | In distribution |
| VLOCL0015 | Length 12 in | In distribution |
| VLOCL0135 | Length 24 in | In distribution |
| VLOCL0824 | Diameter,3/0,N/A; | In distribution |
| VLOCL0124 | Length 18 in | In distribution |
| VLOCA208L | diameter,2/0,N/A; | In distribution |
| VLOCL1904 | diameter, 3/0, N/A; | In distribution |
| VLOCL0305 | Diameter,2/0,N/A; | In distribution |
| VLOCL0416 | Diameter,0,N/A; | In distribution |
| VLOCL0326 | Diameter,0,N/A; | In distribution |
| VLOCL0346 | Diameter,0,N/A; | In distribution |
| VLOCL0644 | Diameter,3/0,N/A; | In distribution |
| VLOCL0604 | Diameter,3/0,N/A; | In distribution |
| VLOCL0643 | Length 9 in | In distribution |
| VLOCL0316 | Diameter,0,N/A; | In distribution |
| VLOCL0003 | Length 6 in | In distribution |
| VLOCL0525 | Diameter,2/0,N/A; | Withdrawn |
| VLOCA304L | Length 4 in | Withdrawn |
| VLOCA004L | Length 4 in | Withdrawn |
| VLOCL0035 | Length 24 in | Withdrawn |
| VLOCL1623 | Diameter,4/0,N/A; | Withdrawn |
| VLOCL1624 | Diameter,3/0,N/A; | Withdrawn |
| VLOCL0314 | Diameter,3/0,N/A; | Withdrawn |
| VLOCA204L | Length 4 in | Withdrawn |
| VLOCL0113 | Diameter,4/0,N/A; | Withdrawn |
| VLOCL0536 | Diameter,0,N/A; | Withdrawn |
| VLOCL0526 | Length 18 in | Withdrawn |
| VLOCL0535 | Diameter,2/0,N/A; | Withdrawn |
| VLOCA306L | Length 6 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2026-06-24 | Class II | Equipment maintenance | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | 135,875 total |
| Covidien | 510(k) number | 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 | 117978 |
| Covidien | 510(k) number | 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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | 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.