V. Mueller Vital Skin Stapler
FDA 510(k) K851974 · American V. Mueller
510(k) numberK851974
Submission
- Device name
- V. Mueller Vital Skin Stapler
- Applicant
- American V. Mueller
Chicago, IL, US - Received
- May 7, 1985
- Decision date
- June 11, 1985
- 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 |
| 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 |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional | 06/12/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K862772 | V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional | 08/18/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K850947 | V-Mueller Inverted Linear Anastomosis InstrumentsGAG · Traditional | 04/17/1985SE |
Questions and answers
When was V. Mueller Vital Skin Stapler cleared by the FDA?
V. Mueller Vital Skin Stapler (K851974) received a 510(k) decision of Substantially Equivalent on June 11, 1985, 35 days after the submission was received.
What is the product code of K851974?
The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.