Suture Tension Adjustment Reel

FDA 510(k) K904136 · Surgical Systems, Inc.

Substantially Equivalent

510(k) numberK904136

Submission

Device name
Suture Tension Adjustment Reel
Applicant
Surgical Systems, Inc.
Miami, FL, US
Received
September 6, 1990
Decision date
October 2, 1990
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
K902001Surgical Retention BarKGS · Traditional Acufex Microsurgical, Inc.05/09/1990SE
K896310Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional Acufex Microsurgical, Inc.11/20/1989SE
K893995Dermacare Tie HolderKGS · Traditional Dermacare08/11/1989SE

More from Dermacare

510(k)DeviceDecision
K802868Accu-Counter Surgical Sponge Counting Sy · Traditional 12/19/1980SE

Questions and answers

When was Suture Tension Adjustment Reel cleared by the FDA?

Suture Tension Adjustment Reel (K904136) received a 510(k) decision of Substantially Equivalent on October 2, 1990, 26 days after the submission was received.

What is the product code of K904136?

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