Staple, Removable (Skin)
FDA product code GDT · Class I (low risk) · 21 CFR 878.4760 · General, Plastic Surgery
19510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Edward Weck, Inc. 3
- ETHICON, Inc. 2
- Prosper, Inc. 2
- 3M Company 1
- Howmedica Corp. 1
- Tri-State 1
- American V. Mueller 1
- Busse Hospital Disposables, Inc. 1
- Davis & Geck, Inc. 1
- United States Surgical, A Division of Tyco Healthc 1
- DeRoyal Industries Inc 1
- Cypress Medical Products, Ltd. 1
- Matsutani Seisakusho Co. , Ltd. 1
- Pilling Weck, Inc. 1
- Continental Medical Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963234 | Staple Removal KitGDT · Traditional | Continental Medical Laboratories, Inc. | 10/21/1996SE |
| K943719 | Visistat StaplerGDT · Traditional | Pilling Weck, Inc. | 08/24/1994SE |
| K925526 | Manipler Disposable Skin StaplerGDT · Traditional | Matsutani Seisakusho Co. , Ltd. | 06/24/1993SE |
| K915430 | Skin Staple Remover KitGDT · Traditional | Cypress Medical Products, Ltd. | 02/28/1992SEKD |
| K911204 | Qualtex Skin Staple ExtractorGDT · Traditional | Deroyal Industries, Inc. | 05/08/1991SE |
| K910586 | Auto Suture(R) Polymer Skin Graft Stapler*GDT · Traditional | United States Surgical, A Division of Tyco Healthc | 03/07/1991SE |
| K900486 | Appose Unity Sterile Disposable Skin StaplerGDT · Traditional | Davis & Geck, Inc. | 04/20/1990SE |
| K861711 | Skin Staple Remover with Sponge Sterile DisposableGDT · Traditional | Busse Hospital Disposables, Inc. | 05/16/1986SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | American V. Mueller | 06/11/1985SE |
| K844838 | Skin Stat II Skin Stapling Medical DeviceGDT · Traditional | Edward Weck, Inc. | 01/23/1985SE |
| K844837 | Visistat Skin Stapling DeviceGDT · Traditional | Edward Weck, Inc. | 01/23/1985SE |
| K833085 | Staple Remover SR300PGDT · Traditional | Prosper, Inc. | 12/14/1984SE |
| K833357 | Vydax 525-550 & 5100 FluorotelomerGDT · Traditional | ETHICON, Inc. | 12/12/1983SE |
| K832709 | Skin Stapling Device SC2000GDT · Traditional | Prosper, Inc. | 09/26/1983SE |
| K822365 | Centurion Skin Staple RemoverGDT · Traditional | Tri-State | 08/27/1982SE |
| K821024 | Disp. Skin Stapler Removalble SkinstapleGDT · Traditional | Howmedica Corp. | 05/14/1982SE |
| K801444 | Skin Staple Remover #523770GDT · Traditional | Edward Weck, Inc. | 07/14/1980SE |
| K800535 | 3M Disposable Skin StaplerGDT · Traditional | 3M Company | 04/04/1980SE |
| K760734 | Regular and Wide Skin StaplesGDT · Traditional | ETHICON, Inc. | 11/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1193-2018 Class II | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6… | Teleflex Medical | 02/15/2018Terminated |
| Z-2108-2017 Class II | WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is…Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat… | Teleflex Medical | 03/24/2017Completed |
| Z-0764-2017 Class II | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC…Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | Teleflex Medical | 11/18/2016Terminated |
| Z-2703-2015 Class II | SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical procedures and…Recall initiated due to inadequate validation/qualification of sterilization processes, and package… | Customed, Inc | 07/10/2015Terminated |
| Z-0250-2015 Class I | Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |