Mono Q
Suture.
4manufacturers in China registered for this device type
73catalogue numbers in this listing
1510(k) clearance
40recalls on this 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 | Riverpoint Medical LLC, United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-24 |
| Record revised | 2022-10-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Q936C | In distribution | |
| Q1425 | In distribution | |
| Q492 | In distribution | |
| Q1415 | In distribution | |
| Q936 | In distribution | |
| Q345 | In distribution | |
| Q315 | In distribution | |
| Q987 | In distribution | |
| Q427C | In distribution | |
| Q361 | In distribution | |
| Q943C | In distribution | |
| Q1520 | In distribution | |
| Q1515 | In distribution | |
| Q513 | In distribution | |
| Q967 | In distribution | |
| Q523 | In distribution | |
| Q417 | In distribution | |
| Q464 | In distribution | |
| Q501 | In distribution | |
| Q392C | In distribution | |
| Q493C | In distribution | |
| Q392U | In distribution | |
| Q497 | In distribution | |
| Q317 | In distribution | |
| Q495C | In distribution | |
| Q732C | In distribution | |
| Q497C | In distribution | |
| Q347 | In distribution | |
| Q388 | In distribution | |
| Q344 | In distribution | |
| Q388U | In distribution | |
| Q1525 | In distribution | |
| Q923 | In distribution | |
| Q496C | In distribution | |
| Q942 | In distribution | |
| Q496 | In distribution | |
| Q426C | In distribution | |
| Q464C | In distribution | |
| Q502C | In distribution | |
| Q367 | In distribution | |
| Q492C | In distribution | |
| Q395U | In distribution | |
| Q395 | In distribution | |
| Q495 | In distribution | |
| Q416 | In distribution | |
| Q493 | In distribution | |
| Q463C | In distribution | |
| Q942C | In distribution | |
| Q399 | In distribution | |
| Q967C | In distribution | |
| Q922C | In distribution | |
| Q426 | In distribution | |
| Q919 | In distribution | |
| Q427 | In distribution | |
| Q346 | In distribution | |
| Q304 | In distribution | |
| Q303 | In distribution | |
| Q463 | In distribution | |
| Q499 | In distribution | |
| Q506 | In distribution | |
| Q317C | In distribution | |
| Q316 | In distribution | |
| Q922 | In distribution | |
| Q388C | In distribution | |
| Q968 | In distribution | |
| Q762 | In distribution | |
| Q346C | In distribution | |
| Q395C | In distribution | |
| Q943 | In distribution | |
| Q513C | In distribution | |
| Q920 | In distribution | |
| Q1420 | In distribution | |
| Q494 | 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 |
|---|---|
| K120556 | 2012-05-23 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-12-09 | Class II | Process control | Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence. | 3060 units | 2023-04-21 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 3103 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 7496 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 10457 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 5596 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 8623 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1236 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 3107 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1886 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1875 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 6150 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1248 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 3109 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1242 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 3110 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1811 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1267 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1276 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1222 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1268 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 5479 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1256 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1270 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1264 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1258 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1262 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 7982 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 3109 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1264 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 9214 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1253 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 8598 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1260 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 9820 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 2499 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1272 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1248 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1266 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 7969 | 2022-09-08 |
| 2020-08-03 | Class II | Under Investigation by firm | The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention. | 1244 | 2022-09-08 |
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.