Glycolon
The FDA filing names GLYCOLON as an absorbable poly(glycolide/l-lactide) surgical suture. It describes the suture for general soft tissue approximation or ligation. The stated use excludes…
The FDA filing names GLYCOLON as an absorbable poly(glycolide/l-lactide) surgical suture. It describes the suture for general soft tissue approximation or ligation.
The stated use excludes cardiovascular and neurological tissues, microsurgery, and ophthalmic surgery. The description here is specific to GLYCOLON, rather than the other sutures named in the same clearance.
Listed Item
GLYCOLON violet 6/0 USP, DSM13, 45 cm (12 pcs)
Stated Use
The filing frames GLYCOLON as a suture used to approximate soft tissue or tie off tissue. Its listed exclusions distinguish this product from the separate PGA RESORBA and PGA RESOQUICK indications in the filing.
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 | Resorba Medical GmbH, Germany |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Manufacturer |
| 510(k) | K143584 |
| Record published | 2019-01-17 |
| Record revised | 2024-09-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GYLCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| CLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | In distribution | |
| GLYCOLON | 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 |
|---|---|
| K181320 | 2018-09-18 |
| K143584 | 2015-11-02 |
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.