Maxon CV
Monofilament Absorbable Suture
4manufacturers in China registered for this device type
23catalogue 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) | K990951 |
| Record published | 2015-08-30 |
| Record revised | 2025-11-04 (version 13) |
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 |
| Sizes | Length 18 to 36 in |
| Distribution end date | 2026-03-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8886 6132-11 | Length 30 in | In distribution |
| 8886 6147-11 | Length 24 in | In distribution |
| 8886 6147-21 | Length 24 in | In distribution |
| 8886 6148-11 | Length 30 in | In distribution |
| 8886 6139-11 | Length 24 in | In distribution |
| 8886 6462-21 | Length 30 in | In distribution |
| 8886 6127-11 | Length 30 in | In distribution |
| 8886 6121-11 | Length 18 in | In distribution |
| 8886 6462-31 | Length 30 in | In distribution |
| 8886 6131-11 | Length 24 in | In distribution |
| 8886 6148-21 | Length 30 in | In distribution |
| 8886 6124-21 | Length 30 in | In distribution |
| 8886 6115-11 | Length 18 in | In distribution |
| 8886 6122-21 | Length 30 in | In distribution |
| 8886 6127-01 | Length 30 in | Withdrawn |
| 8886 6134-31 | Length 36 in | Withdrawn |
| 8886 6165-23 | Length 24 in | Withdrawn |
| 8886 6124-11 | Length 30 in | Withdrawn |
| 8886 6145-01 | Length 18 in | Withdrawn |
| 8886 6165-13 | Length 24 in | Withdrawn |
| 8886 6128-21 | Length 36 in | Withdrawn |
| 8886 6139-01 | Length 24 in | Withdrawn |
| 8886 6149-21 | Length 30 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
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 | Closed |
|---|---|---|---|---|---|---|---|
| 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.