Dermacare Tie Holder

FDA 510(k) K893995 · Dermacare

Substantially Equivalent

510(k) numberK893995

Submission

Device name
Dermacare Tie Holder
Applicant
Dermacare
Louisville, KY, US
Received
June 5, 1989
Decision date
August 11, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KGS – Retention Device, Suture
Device class
Class I (low risk)
Regulation
21 CFR 878.4930
Specialty
General, Plastic Surgery

Other 510(k)s with product code KGS

510(k)DeviceApplicantDecision
K030031Soft Tissue Anchoring WashersKGS · Traditional Accu-Speed, Incorporated01/28/2003SE
K020480RBMKGS · Special Smith & Nephew, Inc.03/12/2002SE
K964935Suture LockKGS · Traditional Smith & Nephew Endoscopy, Inc.02/25/1997SE
K941740Acufex Rotator Cuff Fixation ButtonKGS · Traditional Acufex Microsurgical, Inc.06/30/1995SE
K930675Mitek Cone WasherKGS · Traditional Mitek Surgical Products, Inc.11/09/1993SE
K904435Ventrofil Tension Relief Suture SetKGS · Traditional Aesculap, Inc.08/29/1991SE
K911225Tray DoughKGS · Traditional The Hygenic Corp.04/17/1991SE
K904136Suture Tension Adjustment ReelKGS · Traditional Surgical Systems, Inc.10/02/1990SE
K902001Surgical Retention BarKGS · Traditional Acufex Microsurgical, Inc.05/09/1990SE
K896310Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional Acufex Microsurgical, Inc.11/20/1989SE

More from Acufex Microsurgical, Inc.

510(k)DeviceDecision
K060653ThermaclearGEX · Traditional 10/24/2006SE
K884656Disposable Bipolar Cord and Bipolar ForcepGEI · Traditional 11/25/1988SE

Questions and answers

When was Dermacare Tie Holder cleared by the FDA?

Dermacare Tie Holder (K893995) received a 510(k) decision of Substantially Equivalent on August 11, 1989, 67 days after the submission was received.

What is the product code of K893995?

The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.