Auto Suture(R) Polymer Skin Graft Stapler*
FDA 510(k) K910586 · United States Surgical, A Division of Tyco Healthc
510(k) numberK910586
Submission
- Device name
- Auto Suture(R) Polymer Skin Graft Stapler*
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- February 11, 1991
- Decision date
- March 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDT – Staple, Removable (Skin)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4760
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDT
| 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 |
| 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 |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071406 | Autosuture Endo Clip III 5 MM Clip ApplierFZP · Traditional | 11/21/2007SE |
| K071920 | Autosuture Absorbable Tack and ApplicatorGDW · Traditional | 09/28/2007SE |
| K061288 | Auto Suture Endo Clip III 5 MM Clip ApplierFZP · Special | 11/02/2006SE |
| K062850 | Autosuture Circular Eea Surgical StaplersGDW · Special | 10/23/2006SE |
| K062326 | Autosuture Modified Versaport Trocar with Fixation SleeveGCJ · Special | 09/01/2006SE |
| K061095 | Auto Sutur Endo Gia StaplersGDW · Traditional | 05/31/2006SE |
| K050947 | Modification to: Modified Uss Polypropylene SutureGAW · Special | 06/01/2005SE |
| K042412 | Modified Spacemaker SystemGCJ · Special | 09/24/2004SE |
| K040594 | Herculon Soft Tissue Reattachment SystemHWC · Special | 03/31/2004SE |
| K032696 | Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…GDW · Traditional | 12/01/2003SE |
Questions and answers
When was Auto Suture(R) Polymer Skin Graft Stapler* cleared by the FDA?
Auto Suture(R) Polymer Skin Graft Stapler* (K910586) received a 510(k) decision of Substantially Equivalent on March 7, 1991, 24 days after the submission was received.
What is the product code of K910586?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.