Surgipro II
Monofilament Polypropylene,CV-23,D/A,1x Blue Strand with Soft PTFE Pledget 9.5x4.8x1.5mm
3manufacturers in China registered for this device type
254catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| 510(k) | K010909 |
| Record published | 2020-01-30 |
| Record revised | 2025-11-04 (version 22) |
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 | Storage environment temperature up to 130 °F |
| Packaging | Case of 36, case of 12, case of 24, pack_or_inner_pack of 12, pack_or_inner_pack of 36, pack_or_inner_pack of 24 |
| Sizes | Length 6 to 60 in |
| Distribution end date | 2026-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VP566X-2 | diameter,5/0,N/A; | In distribution |
| VP-744-X | Diameter,8/0,N/A; | In distribution |
| VP872X-2 | Length 30 in | In distribution |
| VP-422X | Length 36 in | In distribution |
| VP-733-X | Diameter,6/0,N/A; | In distribution |
| VP-532X | diameter,3/0,N/A; | In distribution |
| VP-760-X | Diameter,3/0,N/A; | In distribution |
| VP-753-MX | Diameter,8/0,N/A; | In distribution |
| X-1325 | Diameter,3/0,N/A; | In distribution |
| VP703X-2 | diameter,6/0,N/A; | In distribution |
| SP-5587 | Length 30 in | In distribution |
| VP757X-2 | Length 18 in | In distribution |
| XX-5249 | Length 48 in | In distribution |
| VP-205X | diameter,5/0,N/A; | In distribution |
| VP726MX-2 | Length 24 in | In distribution |
| VP555X-2 | diameter,6/0,N/A; | In distribution |
| VP-735-MX | Diameter,7/0,N/A; | In distribution |
| VP582X-2 | Length 36 in | In distribution |
| VP800X-2 | Length 18 in | In distribution |
| VP-765-MX | Diameter,7/0,N/A; | In distribution |
| VP-755-X | Diameter,5/0,N/A; | In distribution |
| XX-3300 | diameter,5/0,N/A; | In distribution |
| XX-5148 | Diameter,2/0,N/A; | In distribution |
| VP-745-X | Diameter,8/0,N/A; | In distribution |
| VP-510X | diameter,5/0,N/A; | In distribution |
| VP-76-X | Diameter,6/0,N/A; | In distribution |
| VP-72-X | Length 24 in | In distribution |
| VP-771-X | Diameter,4/0,N/A; | In distribution |
| VP746X-2 | diameter,6/0,N/A; | In distribution |
| VP-728-X | Diameter,6/0,N/A; | In distribution |
| VP559X-2 | diameter, 2/0, N/A; | In distribution |
| XX-5108 | Length 30 in | In distribution |
| VP-746-X | Diameter,6/0,N/A; | In distribution |
| VP-738-MX | Diameter,8/0,N/A; | In distribution |
| VP-126MX | diameter,6/0,N/A; | In distribution |
| VP-520X | Length 36 in | In distribution |
| VP-761-X | Diameter,4/0,N/A; | In distribution |
| VP-747-MX | Diameter,7/0,N/A; | In distribution |
| VP746MX-2 | diameter,6/0,N/A; | In distribution |
| VP-653-MX | Length 24 in | In distribution |
| VP570X-2 | Length 30 in | In distribution |
| VP584X-2 | diameter,4/0,N/A; | In distribution |
| VP706MX-2 | diameter,6/0,N/A; | In distribution |
| VP-75-X | Length 24 in | In distribution |
| VP-566X | diameter,5/0,N/A; | In distribution |
| VP-37MX | diameter,7/0,N/A; | In distribution |
| VP890X-2 | Length 30 in | In distribution |
| VP556MX-2 | Length 36 in | In distribution |
| XX-5224 | Length 36 in | In distribution |
| VP870X-2 | Length 30 in | In distribution |
| VP585X-2 | diameter,3/0,N/A; | In distribution |
| VP-73-X | Diameter,6/0,N/A; | In distribution |
| 2PPL11670V | Diameter, 7/0, N/A; | In distribution |
| VP-743-MX | Diameter,8/0,N/A; | In distribution |
| VP-435X | diameter,4/0,N/A; | In distribution |
| VP-747-X | Diameter,7/0,N/A; | In distribution |
| VP719X-2 | diameter,5/0,N/A; | In distribution |
| VP-776-X | Diameter,6/0,N/A; | In distribution |
| VP-541X | Length 48 in | In distribution |
| VP813X-2 | diameter,4/0,N/A; | In distribution |
| XX-5159 | Diameter,5/0,N/A; | In distribution |
| VP705MX-2 | Length 30 in | In distribution |
| VP703MX-2 | Length 24 in | In distribution |
| VP718X-2 | Length 18 in | In distribution |
| VP-120MX | diameter,5/0,N/A; | In distribution |
| VP-522X | diameter,3/0,N/A; | In distribution |
| XX-5161 | Diameter,0,N/A; | In distribution |
| VP557X-2 | diameter,4/0,N/A; | In distribution |
| XX-5087 | Diameter,6/0,N/A; | In distribution |
| VP-555X | diameter,6/0,N/A; | In distribution |
| VP-72-MX | Diameter,7/0,N/A; | In distribution |
| VP363X-2 | Length 36 in | In distribution |
| VP-727-X | Diameter,7/0,N/A; | In distribution |
| VP-580X | diameter,5/0,N/A; | In distribution |
| XX-5190J | Length 36 in | In distribution |
| VP365X-2 | diameter,6/0,N/A; | In distribution |
| VP889X-2 | Length 30 in | In distribution |
| SP-5563 | Length 30 in | In distribution |
| X-1360 | Diameter,7/0,N/A; | In distribution |
| X-1307 | Length 48 in | In distribution |
| VP-728-MX | Diameter,6/0,N/A; | In distribution |
| VP881X-2 | Length 30 in | In distribution |
| VP706X-2 | diameter,6/0,N/A; | In distribution |
| XX-5247 | Length 24 in | In distribution |
| X-1319 | Length 36 in | In distribution |
| VP-73-MX | Diameter,6/0,N/A; | In distribution |
| VP-812-X | Diameter,7/0,N/A; | In distribution |
| VP702MX-2 | Length 24 in | In distribution |
| VP-204X | diameter,4/0,N/A; | In distribution |
| VP972X | Length 36 in | In distribution |
| VP-744-MX | Diameter,8/0,N/A; | In distribution |
| VP-751-X | Diameter,5/0,N/A; | In distribution |
| XX-5142 | Diameter,4/0,N/A; | In distribution |
| XX-5168 | Diameter,6/0,N/A; | In distribution |
| VP-738-X | Diameter,8/0,N/A; | In distribution |
| 2PPN12660V | Length 30 in | In distribution |
| XX-5158 | Length 20 in | In distribution |
| X1400 | Length 30 in | In distribution |
| VP-556MX | diameter,5/0,N/A; | In distribution |
| VP581X-2 | diameter,4/0,N/A; | In distribution |
| VP-421X | Length 36 in | In distribution |
| VP713MX-2 | diameter,7/0,N/A; | In distribution |
| VP-737-MX | Length 24 in | In distribution |
| VP871X-2 | Length 30 in | In distribution |
| VP-78-X | Diameter,6/0,N/A; | In distribution |
| VP-772-X | Diameter,7/0,N/A; | In distribution |
| VP-570X | diameter,5/0,N/A; | In distribution |
| VP-754-X | Diameter,6/0,N/A; | In distribution |
| VP558X-2 | Length 36 in | In distribution |
| VP709MX-2 | Length 30 in | In distribution |
| XX2216 | Length 30 in | In distribution |
| VP702X-2 | diameter,7/0,N/A; | In distribution |
| VP86X | diameter, 6/0, N/A; | In distribution |
| VP-734-MX | Diameter,7/0,N/A; | In distribution |
| VP-331X | Length 36 in | In distribution |
| VP-521X | diameter,4/0,N/A; | In distribution |
| VP871XG | Diameter, 4/0, N/A; | In distribution |
| SP-624-BC | Length 30 in | In distribution |
| VP-832-X | Diameter,3/0,N/A; | In distribution |
| XX-2141 | Length 24 in | In distribution |
| VP-76-MX | Diameter,6/0,N/A; | In distribution |
| XX-5167 | Length 30 in | In distribution |
| VP-831-X | Diameter,4/0,N/A; | In distribution |
| VP725X-2 | Length 24 in | In distribution |
| XX-5266 | Length 48 in | In distribution |
| XX-5259 | Length 30 in | In distribution |
| VP763MX | Length 24 in | In distribution |
| VP727X-2 | diameter,7/0,N/A; | In distribution |
| PPK12660V | Diameter, 6/0, N/A; | In distribution |
| XX-5101 | Diameter,5/0,N/A; | In distribution |
| VP701MX-2 | diameter,7/0,N/A; | In distribution |
| VP720MX-2 | diameter,5/0,N/A; | In distribution |
| X-1367 | Diameter,5/0,N/A; | In distribution |
| VP583X-2 | diameter,4/0,N/A; | In distribution |
| VP-763-X | Diameter,8/0,N/A; | In distribution |
| VP-761-MX | Diameter,4/0,N/A; | In distribution |
| VP-209MX | diameter,8/0,N/A; | In distribution |
| VP-735-X | Diameter,7/0,N/A; | In distribution |
| VP-813-X | Diameter,4/0,N/A; | In distribution |
| VP-762-X | Diameter,3/0,N/A; | In distribution |
| VP719MX-2 | Length 18 in | In distribution |
| VP557MX-2 | Length 36 in | In distribution |
| VP720X-2 | diameter,5/0,N/A; | In distribution |
| VP-757-X | Diameter,4/0,N/A; | In distribution |
| VP726X-2 | Length 24 in | In distribution |
| VPP557X-2 | Length 36 in | In distribution |
| VP331X-2 | Length 36 in | In distribution |
| VP681X | diameter, 4/0, N/A; | In distribution |
| VP718MX-2 | Length 18 in | In distribution |
| VP-511X | Length 30 in | In distribution |
| VP725MX-2 | Length 24 in | In distribution |
| VP705X-2 | Length 30 in | In distribution |
| VP-559-X | Length 36 in | In distribution |
| VP-581X | diameter,4/0,N/A; | In distribution |
| VP556X-2 | Length 36 in | In distribution |
| XX-5267 | Length 30 in | In distribution |
| VP-102MX | diameter,7/0,N/A; | In distribution |
| VP709X-2 | diameter,6/0,N/A; | In distribution |
| VP812X-2 | diameter, 7/0, N/A; | In distribution |
| VP713X-2 | diameter,7/0,N/A; | In distribution |
| VP701X-2 | Length 18 in | In distribution |
| VP746XG | Diameter, 6/0, N/A; | In distribution |
| XX-5107 | Length 24 in | In distribution |
| VP-542X | diameter,3/0,N/A; | In distribution |
| VP580X-2 | diameter,5/0,N/A; | In distribution |
| VP-74-X | Diameter,6/0,N/A; | In distribution |
| XX-2100 | Diameter,4/0,N/A; | In distribution |
| VP-733-MX | Diameter,6/0,N/A; | In distribution |
| XX-5117 | Length 36 in | In distribution |
| VP-557MX | diameter,4/0,N/A; | In distribution |
| XX-5170 | Diameter,4/0,N/A; | Withdrawn |
| SP5697GMDL | Length 18 in | Withdrawn |
| VPF-706-MX | Length 30 in | Withdrawn |
| VP366X-2 | Length 36 in | Withdrawn |
| SP5687GMDL | diameter, 3/0, N/A; | Withdrawn |
| XX-5136 | Diameter,0,N/A; | Withdrawn |
| VP-417-X | Length 36 in | Withdrawn |
| XX-5162J | Diameter,10/0,N/A; | Withdrawn |
| XX-5265 | Length 48 in | Withdrawn |
| VP-5265 | diameter,4/0,N/A; | Withdrawn |
| X-1352 | Length 60 in | Withdrawn |
| VPF738MX | Length 24 in | Withdrawn |
| SP-8619G | diameter,4/0,N/A; | Withdrawn |
| SP-8656G | diameter,4/0,N/A; | Withdrawn |
| SP665GMDL | diameter, 3/0, N/A; | Withdrawn |
| XX-5262 | Length 36 in | Withdrawn |
| SP5663GMDL | diameter, 3/0, N/A; | Withdrawn |
| VP-650-MX | diameter,7/0,N/A; | Withdrawn |
| XX-5185 | Length 48 in | Withdrawn |
| X-1297 | Diameter,4/0,N/A; | Withdrawn |
| XX-5251 | Length 30 in | Withdrawn |
| XX-5118 | Length 36 in | Withdrawn |
| VP-986-X | Length 36 in | Withdrawn |
| XX-5110 | Length 30 in | Withdrawn |
| XX-5089 | Length 48 in | Withdrawn |
| SP5681GMDL | diameter, 5/0, N/A; | Withdrawn |
| SP5699GMDL | diameter, 4/0, N/A; | Withdrawn |
| X1390 | Length 24 in | Withdrawn |
| SP5686GMDL | diameter, 5/0, N/A; | Withdrawn |
| SP5698GMDL | diameter, 5/0, N/A; | Withdrawn |
| SP5682GMDL | Length 18 in | Withdrawn |
| X-1304 | Diameter,3/0,N/A; | Withdrawn |
| XX-5205J | Length 24 in | Withdrawn |
| XX-5085 | Diameter,3/0,N/A; | Withdrawn |
| XX-5248 | Length 30 in | Withdrawn |
| X-1358 | Length 36 in | Withdrawn |
| XX-5109 | Length 36 in | Withdrawn |
| XX-5187 | Length 30 in | Withdrawn |
| X-1363 | Diameter,7/0,N/A; | Withdrawn |
| VP756X-2 | diameter,5/0,N/A; | Withdrawn |
| VP-363X | Length 36 in | Withdrawn |
| VP-800-X | Diameter,7/0,N/A; | Withdrawn |
| XX-5191J | Length 36 in | Withdrawn |
| XX-5119 | Length 36 in | Withdrawn |
| VP-776-MX | Diameter,6/0,N/A; | Withdrawn |
| XX-2147 | Length 30 in | Withdrawn |
| VP-751-MX | Diameter,5/0,N/A; | Withdrawn |
| XX-5188 | Length 36 in | Withdrawn |
| VP760MX | diameter, 7/0, N/A; | Withdrawn |
| XX-5264 | Length 48 in | Withdrawn |
| X-1327 | Length 36 in | Withdrawn |
| VP-759-MX | Diameter,7/0,N/A; | Withdrawn |
| VP-366X | Length 36 in | Withdrawn |
| VP-556X | diameter,5/0,N/A; | Withdrawn |
| XX-5207 | Length 36 in | Withdrawn |
| VP-746-MX | Diameter,6/0,N/A; | Withdrawn |
| VP-764-MX | Diameter,6/0,N/A; | Withdrawn |
| XX-2123 | diameter,4/0,N/A; | Withdrawn |
| VPF-710-MX | Length 30 in | Withdrawn |
| XX-2101 | Diameter,6/0,N/A; | Withdrawn |
| VP-558X | Length 36 in | Withdrawn |
| VP-365X | diameter,6/0,N/A; | Withdrawn |
| XX-5106 | Diameter,4/0,N/A; | Withdrawn |
| VPF-557-MX | diameter,4/0,N/A; | Withdrawn |
| X1379 | Length 36 in | Withdrawn |
| VP-756-X | Diameter,5/0,N/A; | Withdrawn |
| X-1351 | Length 30 in | Withdrawn |
| XX-5079 | Length 30 in | Withdrawn |
| X1401 | diameter, 3/0, NA; | Withdrawn |
| VP-5267 | diameter,4/0,N/A; | Withdrawn |
| VP78X-2 | Length 18 in | Withdrawn |
| SP5695GMDL | Length 18 in | Withdrawn |
| XX-5094-L | Diameter,0,N/A; | Withdrawn |
| VP-985-X | Length 36 in | Withdrawn |
| VP-2147 | diameter,4/0,N/A; | Withdrawn |
| VP-552X | diameter,6/0,N/A; | Withdrawn |
| XX-5088 | Diameter,2/0,N/A; | Withdrawn |
| XX-5177 | Length 48 in | Withdrawn |
| XX-5116 | Length 36 in | Withdrawn |
| XX-5095-L | Length 60 in | Withdrawn |
Showing 250 of 254 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Prolene | Ethicon, Inc. | 765 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro ll | Covidien LP | 152 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
| Gore-TEX Suture | W. L. Gore & Associates, Inc. | 113 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 8604 units |
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 |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, 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.