Polysorb
Braided Absorbable Suture, SS-2, D/A, 1x Undyed Strand
4manufacturers in China registered for this device type
732catalogue 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) | K963253 |
| Record published | 2015-09-01 |
| Record revised | 2025-07-15 (version 27) |
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 36, case of 12, case of 24, pack_or_inner_pack of 12, case of 6 |
| Sizes | Length 5 to 144 in; total volume 18 Gallon |
| Distribution end date | 2026-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CL-865 | Length 30 in | In distribution |
| CL-673G | Length 30 in | In distribution |
| CL-919 | Length 36 in | In distribution |
| CL-769 | Length 30 in | In distribution |
| L-115 | Length 60 in | In distribution |
| SL-603 | Length 30 in | In distribution |
| CL-741-L | Length 60 in | In distribution |
| CL-964 | Length 36 in | In distribution |
| CL-971 | Length 36 in | In distribution |
| UL-676 | Diameter,1,N/A; | In distribution |
| CL-740-L | Length 60 in | In distribution |
| CL-381-MG | Length 18 in | In distribution |
| CL-603 | Length 30 in | In distribution |
| GL-882 | Diameter,3/0,N/A; | In distribution |
| GL-332 | Length 36 in | In distribution |
| SL-652 | Length 30 in | In distribution |
| CL-20-MG | Length 18 in | In distribution |
| CL-047 | diameter,1,N/A; | In distribution |
| CL-331 | Length 36 in | In distribution |
| SL-73-MG | Diameter,3/0,N/A; | In distribution |
| SL-690 | Diameter,5/0,N/A; | In distribution |
| CL-840 | Diameter,1,N/A; | In distribution |
| SL-5687 | Diameter,5/0,N/A; | In distribution |
| CL-005 | Length 18 in | In distribution |
| GL-222 | Length 30 in | In distribution |
| 2-CL-852 | Length 36 in | In distribution |
| CL16MGC | Diameter, 2/0, N/A; | In distribution |
| SL-5636 | Diameter,5/0,N/A; | In distribution |
| GL-324 | Length 30 in | In distribution |
| CL-936 | Length 36 in | In distribution |
| CL-930 | diameter,2/0,N/A; | In distribution |
| GL-61-MG | Length 18 in | In distribution |
| CLT-11-MG | Diameter,1,N/A; | In distribution |
| GL-183 | Length 30 in | In distribution |
| CL-871 | Length 30 in | In distribution |
| L-1756K | Length 12 in | In distribution |
| GL-47-MG | Length 18 in | In distribution |
| CLT-15-MG | Length 18 in | In distribution |
| CL-536 | Length 30 in | In distribution |
| CL-956 | Length 36 in | In distribution |
| SL-1654 | Diameter,3/0,N/A; | In distribution |
| CL-633-M | Length 18 in | In distribution |
| CL-779 | Length 30 in | In distribution |
| SL-638 | Diameter,4/0,N/A; | In distribution |
| CL-927 | Length 36 in | In distribution |
| L-114 | Length 60 in | In distribution |
| CL-55-MG | Length 18 in | In distribution |
| SL-692 | Diameter,4/0,N/A; | In distribution |
| CL-970 | Length 36 in | In distribution |
| CL-13-MG | diameter,2/0,N/A; | In distribution |
| CL-982 | Length 60 in | In distribution |
| CL-803 | Length 30 in | In distribution |
| CL-202-M | Length 18 in | In distribution |
| SL-691 | Diameter,4/0,N/A; | In distribution |
| CL-30-MG | Length 18 in | In distribution |
| GLJ-57-M | Diameter,3/0,N/A; | In distribution |
| SL-695 | Diameter,4/0,N/A; | In distribution |
| CL-893 | Diameter,2/0,N/A; | In distribution |
| CL-955 | Length 36 in | In distribution |
| CLT-953 | Length 36 in | In distribution |
| L-2800 | Length 5 in | In distribution |
| SL-5629 | Diameter,4/0,N/A; | In distribution |
| UL-240 | Diameter,0,N/A; | In distribution |
| L-406 | Diameter,2,N/A; | In distribution |
| ULJ-56-M | Length 18 in | In distribution |
| L-41 | Length 30 in | In distribution |
| GL-129 | Diameter,1,N/A; | In distribution |
| CL-932 | diameter,1,N/A; | In distribution |
| CL-965 | diameter,1,N/A; | In distribution |
| SL-612 | Length 30 in | In distribution |
| SL-5690 | Diameter,4/0,N/A; | In distribution |
| L-1669-K | Length 18 in | In distribution |
| CLT-855 | Diameter,1,N/A; | In distribution |
| CLT-623-M | Length 18 in | In distribution |
| L-1897K | Length 18 in | In distribution |
| CLT-259 | Length 30 in | In distribution |
| CL-915 | Length 36 in | In distribution |
| L-1785K | Length 12 in | In distribution |
| SL-654 | Diameter,4/0,N/A; | In distribution |
| CL-851-M | Length 18 in | In distribution |
| CL-914 | Length 36 in | In distribution |
| XX-5195-J | Length 30 in | In distribution |
| SL-5641G | Diameter,4/0,N/A; | In distribution |
| CL-946 | Length 36 in | In distribution |
| SL-172 | Diameter,5/0,N/A; | In distribution |
| SL-5620 | Diameter,4/0,N/A; | In distribution |
| SL-636 | Diameter,3/0,N/A; | In distribution |
| SL-5688-G | Diameter,6/0,N/A; | In distribution |
| GL-224 | Length 30 in | In distribution |
| L-1670-K | Length 18 in | In distribution |
| GL-45-MG | Diameter,5/0,N/A; | In distribution |
| CL-939 | diameter,2,N/A; | In distribution |
| SL-693 | Length 30 in | In distribution |
| SL-653 | Diameter,3/0,N/A; | In distribution |
| CL-831 | Diameter,0,N/A; | In distribution |
| L-39 | Length 30 in | In distribution |
| CL-369-MG | diameter,2/0,N/A; | In distribution |
| SL-714 | Diameter,2/0,N/A; | In distribution |
| CL-922 | Length 36 in | In distribution |
| CL-533 | Length 36 in | In distribution |
| GL-121 | Diameter,4/0,N/A; | In distribution |
| L-11 | Length 18 in | In distribution |
| GL-126 | Length 30 in | In distribution |
| CL-974 | Length 36 in | In distribution |
| CL-979 | Diameter,2,N/A; | In distribution |
| CL-905 | Length 36 in | In distribution |
| GL-128 | Diameter,0,N/A; | In distribution |
| SL-5679 | Diameter,3/0,N/A; | In distribution |
| L-405 | Length 30 in | In distribution |
| L-1791K | Length 18 in | In distribution |
| LL-323 | Diameter,2/0,N/A; | In distribution |
| CL-944 | Length 36 in | In distribution |
| SL-696 | Diameter,3/0,N/A; | In distribution |
| CL-6-M | Length 30 in | In distribution |
| GL-523 | Length 30 in | In distribution |
| CL-845 | Length 30 in | In distribution |
| SL-691G | Diameter,4/0,N/A; | In distribution |
| CL-841 | Length 30 in | In distribution |
| L-1796K | Diameter,7/0,N/A; | In distribution |
| GL-69-MG | Length 18 in | In distribution |
| CL-240-M | diameter,0,N/A; | In distribution |
| SL-635G | Diameter,4/0,N/A; | In distribution |
| UL-879 | Length 30 in | In distribution |
| CL-805 | Length 30 in | In distribution |
| EL-450 | diameter,3/0,N/A; | In distribution |
| CL-644-M | Length 24 in | In distribution |
| SL-1660 | Diameter,6/0,N/A; | In distribution |
| CL-538 | diameter,1,N/A; | In distribution |
| CL-462 | Length 30 in | In distribution |
| GL-192 | Length 30 in | In distribution |
| SL-642 | Diameter,2/0,N/A; | In distribution |
| CL-568 | Length 30 in | In distribution |
| L-116 | Length 60 in | In distribution |
| CL-271 | Length 36 in | In distribution |
| CL-12-MG | diameter,3/0,N/A; | In distribution |
| CL-968 | Length 36 in | In distribution |
| GL-890 | Length 30 in | In distribution |
| CL-839 | Length 30 in | In distribution |
| GL-124 | Length 30 in | In distribution |
| SL-5626 | Diameter,5/0,N/A; | In distribution |
| CL-15-MG | Length 18 in | In distribution |
| CL-376-MG | Length 18 in | In distribution |
| GL-303 | Diameter,3/0,N/A; | In distribution |
| LL-111 | Diameter,4/0,N/A; | In distribution |
| L-1787K | Length 18 in | In distribution |
| L-1745K | Diameter,6/0,N/A; | In distribution |
| L-1750K | Length 18 in | In distribution |
| CL-864 | Length 30 in | In distribution |
| L-42 | Length 30 in | In distribution |
| SL-1653 | Diameter,4/0,N/A; | In distribution |
| CL-934 | Length 30 in | In distribution |
| SL-171 | Diameter,6/0,N/A; | In distribution |
| L-43 | Length 30 in | In distribution |
| SL-634 | Length 30 in | In distribution |
| SL-822G | Diameter,3/0,N/A; | In distribution |
| L-2753K | Length 18 in | In distribution |
| CL-929 | diameter,2,N/A; | In distribution |
| UL-202 | Diameter,5/0,N/A; | In distribution |
| CL-814 | Length 30 in | In distribution |
| CL-370-MG | Length 18 in | In distribution |
| CL-383-MG | Length 18 in | In distribution |
| SL-631 | Diameter,2/0,N/A; | In distribution |
| CL-52-MG | Length 18 in | In distribution |
| CL-358-MG | diameter,1,N/A; | In distribution |
| L-14 | Diameter,0,N/A; | In distribution |
| GL-122 | Length 30 in | In distribution |
| SL-5632 | Diameter,5/0,N/A; | In distribution |
| UL-203 | Diameter,4/0,N/A; | In distribution |
| SL-611 | Diameter,2/0,N/A; | In distribution |
| GL-127 | Length 30 in | In distribution |
| CL-969 | diameter,2,N/A; | In distribution |
| GL-223 | Length 30 in | In distribution |
| SL-5627-G | Diameter,4/0,N/A; | In distribution |
| CL-5-M | Length 30 in | In distribution |
| CL-882 | Diameter,3/0,N/A; | In distribution |
| SL-675 | Diameter,2,N/A; | In distribution |
| CL-843 | Diameter,2/0,N/A; | In distribution |
| CL-906 | Length 36 in | In distribution |
| CL-71-M | Length 30 in | In distribution |
| CL-869 | Diameter,2/0,N/A; | In distribution |
| CL-015 | diameter,2/0,N/A; | In distribution |
| CL-2M | diameter,0,N/A; | In distribution |
| CL-972 | Length 36 in | In distribution |
| CL-917 | Length 36 in | In distribution |
| CL-977 | Length 60 in | In distribution |
| SL-630 | Diameter,5/0,N/A; | In distribution |
| SL-586 | Length 30 in | In distribution |
| EL-440 | diameter,3/0,N/A; | In distribution |
| L-2 | Length 18 in | In distribution |
| XX-5242 | Length 30 in | In distribution |
| CL-950 | diameter,0,N/A; | In distribution |
| L-1792K | Length 18 in | In distribution |
| CL-992 | Length 60 in | In distribution |
| CL-581 | Diameter,1,N/A; | In distribution |
| L-1 | Length 18 in | In distribution |
| CL-542 | Length 30 in | In distribution |
| GL889-2 | Diameter, 6/0, N/A; | In distribution |
| SL-644 | Diameter,4/0,N/A; | In distribution |
| L-25 | Diameter,1,N/A; | In distribution |
| L-5 | Length 18 in | In distribution |
| GL-524 | Length 30 in | In distribution |
| LL-102 | Length 60 in | In distribution |
| CL-925 | Length 36 in | In distribution |
| CL-824-L | Length 48 in | In distribution |
| GLT-69-MG | Length 18 in | In distribution |
| CL-677 | Length 30 in | In distribution |
| CL-824 | Length 60 in | In distribution |
| CL-830 | Diameter,2/0,N/A; | In distribution |
| CL-22-MG | diameter,2/0,N/A; | In distribution |
| CL-460 | Length 30 in | In distribution |
| UL-245 | Length 30 in | In distribution |
| GL-33-MG | Diameter,3/0,N/A; | In distribution |
| SL-5680 | Diameter,2/0,N/A; | In distribution |
| GL-182-M | Length 30 in | In distribution |
| CLT-958 | Diameter,1,N/A; | In distribution |
| LL-226 | Diameter,2,N/A; | In distribution |
| GL-321 | Length 30 in | In distribution |
| CL-844 | Length 30 in | In distribution |
| CLT-13-MG | Length 18 in | In distribution |
| L-2748K | Length 12 in | In distribution |
| GL-46-MG | Diameter,4/0,N/A; | In distribution |
| L-1742K | Length 12 in | In distribution |
| CL-829 | Diameter,3/0,N/A; | In distribution |
| GL-228 | Length 30 in | In distribution |
| SL-5641 | Length 18 in | In distribution |
| CL-801 | Length 30 in | In distribution |
| CL-870 | Length 30 in | In distribution |
| GLJ-51-M | Length 18 in | In distribution |
| L-40 | Diameter,0,N/A; | In distribution |
| SL-822 | Diameter,3/0,N/A; | In distribution |
| GL-125 | Length 36 in | In distribution |
| CL-8-MG | Diameter,3/0,N/A; | In distribution |
| SL-1656 | Length 18 in | In distribution |
| GLS-123 | Length 30 in | In distribution |
| SL-431 | Diameter,4/0,N/A; | In distribution |
| CL-812 | Length 30 in | In distribution |
| CL-928 | Length 36 in | In distribution |
| CL-659-M | Length 30 in | In distribution |
| LL-104 | Diameter,0,N/A; | In distribution |
| SL-1659 | Diameter,5/0,N/A; | In distribution |
| GL-885 | Diameter,5/0,N/A; | In distribution |
| EL-415 | diameter,3/0,N/A; | In distribution |
| CL-916 | Length 36 in | In distribution |
| GL-67-M | Length 30 in | In distribution |
| GLJ-54-M | Length 18 in | In distribution |
| SL-1614G | Diameter,5/0,N/A; | In distribution |
| UL201-2 | Diameter, 6/0, N/A; | In distribution |
| CL-818 | Diameter,1,N/A; | In distribution |
| L-2574K | Length 8 in | In distribution |
| L-104 | Length 60 in | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 319 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2018-06-15 | Class II | Nonconforming Material/Component | Potential proplylene glycol contamination | 972 units | 2019-05-08 |
| Covidien | 510(k) number | 2017-05-03 | Class II | Process control | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. | 478,465 (total for all products) | 2019-07-18 |
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.