Sinusorb® PGA
38 catalogue numbers from 8143, listed by Peters Surgical, France, under Suture, Absorbable, Synthetic, Polyglycolic Acid. 4 manufacturers in China are registered for this product code.
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 | Peters Surgical, France |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K062366 |
| Record published | 2020-01-09 |
| Record revised | 2023-07-12 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8143 | In distribution | |
| 8110 | In distribution | |
| 8134 | In distribution | |
| 8108 | In distribution | |
| 8120 | In distribution | |
| 8135 | In distribution | |
| 8137 | In distribution | |
| 8139 | In distribution | |
| 8126 | In distribution | |
| 8109 | In distribution | |
| 8102 | In distribution | |
| 8104 | In distribution | |
| 8140 | In distribution | |
| 8111 | In distribution | |
| 8138 | In distribution | |
| 8129 | In distribution | |
| 8112 | In distribution | |
| 8133 | In distribution | |
| 8124 | In distribution | |
| 8107 | In distribution | |
| 8131 | In distribution | |
| 8144 | In distribution | |
| 8101 | In distribution | |
| 8113 | In distribution | |
| 8121 | In distribution | |
| 8132 | In distribution | |
| 8106 | In distribution | |
| 8114 | In distribution | |
| 8142 | In distribution | |
| 8136 | In distribution | |
| 8128 | In distribution | |
| 8146 | In distribution | |
| 8123 | In distribution | |
| 8130 | In distribution | |
| 8118 | In distribution | |
| 8125 | In distribution | |
| 8117 | In distribution | |
| 8127 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233265 | 2024-10-11 |
| K232372 | 2024-07-12 |
| K062366 | 2006-10-02 |
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.