Skin Staple Remover with Sponge Sterile Disposable
FDA 510(k) K861711 · Busse Hospital Disposables, Inc.
510(k) numberK861711
Submission
- Device name
- Skin Staple Remover with Sponge Sterile Disposable
- Applicant
- Busse Hospital Disposables, Inc.
Hauppauge, NY, US - Received
- May 5, 1986
- Decision date
- May 16, 1986
- 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 |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
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| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | 06/08/2011SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K063018 | Glass Loss of Resistance SyringeCAZ · Traditional | 01/22/2007SE |
Questions and answers
When was Skin Staple Remover with Sponge Sterile Disposable cleared by the FDA?
Skin Staple Remover with Sponge Sterile Disposable (K861711) received a 510(k) decision of Substantially Equivalent on May 16, 1986, 11 days after the submission was received.
What is the product code of K861711?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.