Skin Staple Remover Kit

FDA 510(k) K915430 · Cypress Medical Products, Ltd.

Unknown

510(k) numberK915430

Submission

Device name
Skin Staple Remover Kit
Applicant
Cypress Medical Products, Ltd.
Mc Henry, IL, US
Received
December 2, 1991
Decision date
February 28, 1992
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K963234Staple Removal KitGDT · Traditional Continental Medical Laboratories, Inc.10/21/1996SE
K943719Visistat StaplerGDT · Traditional Pilling Weck, Inc.08/24/1994SE
K925526Manipler Disposable Skin StaplerGDT · Traditional Matsutani Seisakusho Co. , Ltd.06/24/1993SE
K911204Qualtex Skin Staple ExtractorGDT · Traditional Deroyal Industries, Inc.05/08/1991SE
K910586Auto Suture(R) Polymer Skin Graft Stapler*GDT · Traditional United States Surgical, A Division of Tyco Healthc03/07/1991SE
K900486Appose Unity Sterile Disposable Skin StaplerGDT · Traditional Davis & Geck, Inc.04/20/1990SE
K861711Skin Staple Remover with Sponge Sterile DisposableGDT · Traditional Busse Hospital Disposables, Inc.05/16/1986SE
K851974V. Mueller Vital Skin StaplerGDT · Traditional American V. Mueller06/11/1985SE
K844838Skin Stat II Skin Stapling Medical DeviceGDT · Traditional Edward Weck, Inc.01/23/1985SE
K844837Visistat Skin Stapling DeviceGDT · Traditional Edward Weck, Inc.01/23/1985SE

More from Edward Weck, Inc.

510(k)DeviceDecision
K021676Cypress Medical Products, LP Disposable Vaginal Speculum, Non-MetalHIB · Traditional 07/12/2002SE
K012282Sterile Powder Free Synthetic Vinyl Patient Exam GloveLYZ · Traditional 08/06/2001SE
K972899Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional 07/07/1998SE
K972849Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional 05/28/1998SE
K972883Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional 02/26/1998SE
K952367Cypress Medical Products Vinyl Examination GloveLYY · Traditional 07/05/1995SE
K950254Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional 03/31/1995SE
K950109Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional 02/27/1995SESK
K950092Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional 02/27/1995SESK
K945082Cypress Medical Products StethoscopeLDE · Traditional 12/08/1994SE

Questions and answers

When was Skin Staple Remover Kit cleared by the FDA?

Skin Staple Remover Kit (K915430) received a 510(k) decision of Unknown on February 28, 1992, 88 days after the submission was received.

What is the product code of K915430?

The FDA product code is GDT – Staple, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4760.