Q-Stop
The device is designed to be placed temporarily over a skin incision to assist with holding suture tension prior to final closure.
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | DRS Vascular, Inc., United States |
|---|---|
| FDA product code | KGS |
| Device type | Retention Device, Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4930 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-23 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| QS | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 20 |
| Xtendobutton | Smith & Nephew, Inc. | 7 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 4 |
| Retention Device, Suture | Smith & Nephew, Inc. | 2 |
| Vive | Vive Health LLC | 2 |
| Perchik | AngioDynamics, Inc. | 2 |
| FlowStasis | Inari Medical, Inc. | 2 |
| Stent Buttons | Boston Medical Products, Inc. | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Slip-Not® | Merit Medical Systems, Inc. | 2 |
| Poly Suture Button | Biomet Sports Medicine | 2 |
Showing 12 of 29. All products under Retention Device, Suture
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2025-05-16 | Class II | Device Design | XXX | 264 |
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.