Disp. Skin Stapler Removalble Skinstaple
FDA 510(k) K821024 · Howmedica Corp.
510(k) numberK821024
Submission
- Device name
- Disp. Skin Stapler Removalble Skinstaple
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- April 13, 1982
- Decision date
- May 14, 1982
- 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 |
| 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 |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Disp. Skin Stapler Removalble Skinstaple cleared by the FDA?
Disp. Skin Stapler Removalble Skinstaple (K821024) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 31 days after the submission was received.
What is the product code of K821024?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.