Panels › General, Plastic Surgery › Product code GDT · Class 1
Staple, Removable (Skin)
Regulation 878.4760
0510(k)s in 12 months (19 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in GDT
| Company | 510(k)s | Recalls |
|---|---|---|
| Edward Weck, Inc. | 3 | 0 |
| Teleflex Medical | 0 | 3 |
| Customed, Inc | 0 | 2 |
| ETHICON, Inc. | 2 | 0 |
| Prosper, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| American V. Mueller | 1 | 0 |
| Busse Hospital Disposables, Inc. | 1 | 0 |
| Continental Medical Laboratories, Inc. | 1 | 0 |
| Cypress Medical Products, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Teleflex Medical Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations. Terminated |
GDT | None listed |
| Mar 24, 2017 | Teleflex Medical WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO,
Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of ge Completed |
GDT | None listed |
| Nov 18, 2016 | Teleflex Medical WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709.
The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide Terminated |
GDT | None listed |
| Sep 3, 2015 | Customed, Inc SKIN STAPLE REMOVER KIT 80/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
GDT | None listed |
| Dec 16, 2014 | Customed, Inc Skin Staple Removal, Catalog number 900-782.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
GDT | None listed |
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