Caprosyn
Monofilament Absorbable Suture,GS-22,(5),D-Tach,5x Undyed Strands
4manufacturers in China registered for this device type
147catalogue 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) | K032586 |
| Record published | 2015-08-31 |
| Record revised | 2026-04-28 (version 17) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 130 °F |
| Packaging | Case of 36, case of 12, pack_or_inner_pack of 12, case of 24, box of 12 |
| Sizes | Length 12 to 60 in |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CC-811 | Diameter,2/0,N/A; | In distribution | |
| CC-1945G | Diameter,2/0,N/A; | In distribution | |
| CC-813 | Diameter,1,N/A; | In distribution | |
| CC-975 | Diameter,1,N/A; | In distribution | |
| CC-913 | Diameter,0,N/A; | In distribution | |
| SC-643 | diameter,3/0,N/A; | In distribution | |
| GC-321 | diameter,4/0,N/A; | In distribution | |
| X-1237 | Diameter,2/0,N/A; | In distribution | |
| CC-843 | Diameter,2/0,N/A; | In distribution | |
| SC-5688G | diameter,6/0,N/A; | In distribution | |
| SC-5780G | Length 30 in | In distribution | |
| GC-123 | diameter,2/0,N/A; | In distribution | |
| CC-830 | Diameter,2/0,N/A; | In distribution | |
| CC-844 | Diameter,0,N/A; | In distribution | |
| SC-693 | diameter,2/0,N/A; | In distribution | |
| SC-5590G | diameter,4/0,N/A; | In distribution | |
| UC-863 | Diameter,2/0,N/A; | In distribution | |
| X-1202 | Diameter,5/0,N/A; | In distribution | |
| CC-925 | Diameter,1,N/A; | In distribution | |
| SC-5640 | diameter,3/0,N/A; | In distribution | |
| GC-33-M | diameter,3/0,N/A; | In distribution | |
| CC-905 | Diameter,1,N/A; | In distribution | |
| XX-2205 | Diameter,4/0,N/A; | In distribution | |
| SC-586 | Length 30 in | In distribution | |
| CC-872 | Diameter,2/0,N/A; | In distribution | |
| CC-924 | Diameter,0,N/A; | In distribution | |
| SC-694G | diameter,3/0,N/A; | In distribution | |
| UC-214 | Diameter,4/0,N/A; | In distribution | |
| GC-121 | diameter,4/0,N/A; | In distribution | |
| CC-196 | Diameter,1,N/A; | In distribution | |
| SC-5642G | diameter,5/0,N/A; | In distribution | |
| SC-5626G | diameter,5/0,N/A; | In distribution | |
| SC-5635G | diameter,6/0,N/A; | In distribution | |
| SC-691 | Length 30 in | In distribution | |
| SC-5626 | diameter,5/0,N/A; | In distribution | |
| SC-5637G | diameter,4/0,N/A; | In distribution | |
| C-212 | Diameter,3/0,N/A; | In distribution | |
| UC-204 | Length 30 in | In distribution | |
| SC-542 | Length 30 in | In distribution | |
| CC-983 | Length 60 in | In distribution | |
| CC-803 | Diameter,1,N/A; | In distribution | |
| CC-883 | Diameter,2/0,N/A; | In distribution | |
| CC-922 | Diameter,3/0,N/A; | In distribution | |
| SC-5779 | diameter,4/0,N/A; | In distribution | |
| SC3634G | Length 18 in | In distribution | |
| CC-884 | Diameter,0,N/A; | In distribution | |
| SC-543 | diameter,3/0,N/A; | In distribution | |
| SC-5588G | diameter,6/0,N/A; | In distribution | |
| SC-5587G | diameter,5/0,N/A; | In distribution | |
| UC-403 | Length 30 in | In distribution | |
| SC-5627G | diameter,4/0,N/A; | In distribution | |
| SC-5638G | diameter,3/0,N/A; | In distribution | |
| SC-5686G | diameter,4/0,N/A; | In distribution | |
| CC-912 | Length 36 in | In distribution | |
| SC-3625G | diameter,6/0,N/A; | In distribution | |
| SC-692 | Length 30 in | In distribution | |
| SC-644 | diameter,4/0,N/A; | In distribution | |
| CC-810 | Diameter,3/0,N/A; | In distribution | |
| SC-5616G | diameter,5/0,N/A; | In distribution | |
| GC-323 | diameter,2/0,N/A; | In distribution | |
| SC-5689G | diameter,5/0,N/A; | In distribution | |
| CC-812 | Diameter,0,N/A; | In distribution | |
| GC-122 | diameter,3/0,N/A; | In distribution | |
| SC-5643G | diameter,4/0,N/A; | In distribution | |
| SC-693G | diameter,3/0,N/A; | In distribution | |
| CC-801 | Diameter,2/0,N/A; | In distribution | |
| SC-5617G | diameter,4/0,N/A; | In distribution | |
| CC-543 | Diameter,2/0,N/A; | In distribution | |
| SC-3634 | Length 18 in | In distribution | |
| X-1353 | diameter,1,N/A; | In distribution | |
| CC-802 | Diameter,0,N/A; | In distribution | |
| CC-904 | Diameter,0,N/A; | In distribution | |
| CC-885 | Diameter,1,N/A; | In distribution | |
| CC-845 | Diameter,1,N/A; | In distribution | |
| CC-923 | Diameter,2/0,N/A; | In distribution | |
| C-214 | Diameter,0,N/A; | In distribution | |
| CC-914 | Diameter,1,N/A; | In distribution | |
| CC-831 | Diameter,0,N/A; | In distribution | |
| XX-5122 | Diameter,6/0,N/A; | In distribution | |
| UC-404 | Length 30 in | In distribution | |
| SC-3626G | diameter,5/0,N/A; | In distribution | |
| UC-203 | Length 30 in | In distribution | |
| SC-587 | diameter,3/0,N/A; | In distribution | |
| UC-879 | Length 30 in | In distribution | |
| CC-915 | Diameter,2/0,N/A; | In distribution | |
| SC-585 | diameter,0,N/A; | In distribution | |
| XX-5099 | Length 30 in | In distribution | |
| SC-5618G | diameter,3/0,N/A; | In distribution | |
| CC-658 | Diameter,2/0,N/A; | In distribution | |
| UC-978 | Length 30 in | In distribution | |
| UC-202 | Length 30 in | In distribution | |
| GC-322 | diameter,3/0,N/A; | In distribution | |
| XX-5149 | Length 30 in | In distribution | |
| SC-5690G | diameter,4/0,N/A; | In distribution | |
| SC-5679 | Length 18 in | In distribution | |
| SC-690G | diameter,4/0,N/A; | In distribution | |
| GC-124 | diameter,0,N/A; | In distribution | |
| XX-5245 | Diameter,0,N/A; | Withdrawn | |
| X-1203 | Diameter,6/0,N/A; | Withdrawn | |
| XX-5183 | Diameter,4/0,N/A; | Withdrawn | |
| XX-5196 | Length 30 in | Withdrawn | |
| SC586G | Length 30 in | Withdrawn | |
| CC813G | Length 30 in | Withdrawn | |
| GC123G | Length 30 in | Withdrawn | |
| X-1125 | Diameter,3/0,N/A; | Withdrawn | |
| SC-3639G | diameter,2/0,N/A; | Withdrawn | |
| XX-5098 | Diameter,3/0,N/A; | Withdrawn | |
| CC-641 | diameter,1,N/A; | Withdrawn | |
| C-213 | Diameter,2/0,N/A; | Withdrawn | |
| LC-112 | diameter,3/0,N/A; | Withdrawn | |
| CC913G | diameter,0/N/A; | Withdrawn | |
| XC-490 | Diameter,5/0,N/A; | Withdrawn | |
| CC-100-M | Length 18 in | 5 | Withdrawn |
| XC-834 | Diameter,5/0,N/A; | Withdrawn | |
| XC-822 | Length 18 in | Withdrawn | |
| UC213G | diameter,3/0,N/A; | Withdrawn | |
| CC-38-M | Length 30 in | 5 | Withdrawn |
| CC-942 | Diameter,0,N/A; | Withdrawn | |
| UC-246 | Length 30 in | Withdrawn | |
| LC-113 | diameter,2/0,N/A; | Withdrawn | |
| XX-5157 | Diameter,2/0,N/A; | Withdrawn | |
| XX-5156 | Diameter,3/0,N/A; | Withdrawn | |
| GC-690 | diameter,4/0,N/A; | Withdrawn | |
| CC-558 | Diameter,2/0,N/A; | Withdrawn | |
| UC-213 | Length 30 in | Withdrawn | |
| C-3794GK | Diameter,6/0,N/A; | Withdrawn | |
| C-1780GK | diameter,6/0,N/A; | Withdrawn | |
| CC905G | diameter,1,N/A; | Withdrawn | |
| X-1185 | Diameter,2/0,N/A; | Withdrawn | |
| CC-964 | Diameter,0,N/A; | Withdrawn | |
| CC-974 | Diameter,0,N/A; | Withdrawn | |
| GC-225 | Length 30 in | Withdrawn | |
| XC-845 | Diameter,4/0,N/A; | Withdrawn | |
| X-1200 | Diameter,2/0,N/A; | Withdrawn | |
| CC-824 | Diameter,0,N/A; | Withdrawn | |
| LC-114 | diameter,0,N/A; | Withdrawn | |
| UC-201 | Diameter,6/0,N/A; | Withdrawn | |
| XC-823 | Diameter,4/0,N/A; | Withdrawn | |
| XX-5074 | Diameter,3/0,N/A; | Withdrawn | |
| GC-69-M | diameter,3/0,N/A; | Withdrawn | |
| CC811G | Length 30 in | Withdrawn | |
| XC-844 | Diameter,5/0,N/A; | Withdrawn | |
| UC203G | Length 30 in | Withdrawn | |
| CC-1744 | Length 30 in | Withdrawn | |
| XX-5225 | Diameter,2/0,N/A; | Withdrawn | |
| GC-127 | diameter,2/0,N/A; | Withdrawn | |
| XC-497 | Length 18 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
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.