Qualtex Skin Staple Extractor
FDA 510(k) K911204 · Deroyal Industries, Inc.
510(k) numberK911204
Submission
- Device name
- Qualtex Skin Staple Extractor
- Applicant
- Deroyal Industries, Inc.
Powell, TN, US - Received
- March 19, 1991
- Decision date
- May 8, 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 |
| 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 |
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Questions and answers
When was Qualtex Skin Staple Extractor cleared by the FDA?
Qualtex Skin Staple Extractor (K911204) received a 510(k) decision of Substantially Equivalent on May 8, 1991, 50 days after the submission was received.
What is the product code of K911204?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.