Staple Removal Kit
FDA 510(k) K963234 · Continental Medical Laboratories, Inc.
510(k) numberK963234
Submission
- Device name
- Staple Removal Kit
- Applicant
- Continental Medical Laboratories, Inc.
Waterford, WI, US - Received
- August 19, 1996
- Decision date
- October 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964827 | Prod. No. 01-132 - Suture Removal KitMCZ · Traditional | 02/14/1997SE |
| K963443 | Prod. No. 02-031 - Laceration TrayLRO · Traditional | 10/17/1996SE |
| K962078 | Tracheostomy Cleaning Tray W/Suction CatheterJOH · Traditional | 10/11/1996SESK |
| K954728 | Prod No. 01-1694 - 4X4 Foam DressingKMF · Traditional | 09/23/1996SN |
| K962073 | Urethral Catheterization Tray/Universal Urethral Cath TrayFCM · Traditional | 06/21/1996SE |
| K952335 | Wound Care Management KitsLYY · Traditional | 06/14/1995SE |
| K905123 | G-Tube Dressing Change TrayMCY · Traditional | 03/27/1991SE |
Questions and answers
When was Staple Removal Kit cleared by the FDA?
Staple Removal Kit (K963234) received a 510(k) decision of Substantially Equivalent on October 21, 1996, 63 days after the submission was received.
What is the product code of K963234?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.