3 in 1 Automatic Tourniquet

FDA 510(k) K880020 · Systematics Mfg. & Tool Co., Inc.

Substantially Equivalent

510(k) numberK880020

Submission

Device name
3 in 1 Automatic Tourniquet
Applicant
Systematics Mfg. & Tool Co., Inc.
Bohemia, NY, US
Received
January 5, 1988
Decision date
March 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KCY – Tourniquet, Pneumatic
Device class
Class I (low risk)
Regulation
21 CFR 878.5910
Specialty
General, Plastic Surgery

Other 510(k)s with product code KCY

510(k)DeviceApplicantDecision
K202919ATS 5000 Automatic Tourniquet InstrumentKCY · Traditional Mcewen and Associates Consulting , Ltd.05/20/2021SE
K162365T-CuffKCY · Traditional Terumobct, Inc.02/16/2017SE
K123553Zimmer A.T.S. 4000TS Automatic Tourniquet SystemKCY · Traditional Zimmer, Inc.08/09/2013SE
K112874Ez Vein Inflatable TourniquetKCY · Traditional Dominion Medical Devices, LLC10/17/2011SE
K071140MRI Compatible Thigh Tourniquet, Model C070002KCY · Traditional Top Spins, Inc.06/07/2007SE
K050411Zimmer A.T.S. 3000 Automatic Tourniquet SystemKCY · Traditional Zimmer, Inc.09/02/2005SE
K012632Tourniquet Cuff; Pneumatic TourniquetKCY · Traditional Medical Instruments Technology, Inc.10/26/2001SE
K955552Expressaire Toruniquet SystemKCY · Traditional Smith & Nephew Richards, Inc.01/05/1996SE
K954201Buonafede Pneumatic SleeveKCY · Traditional Promedic, Inc.11/09/1995SE
K954103Tourni-CompKCY · Traditional Scandinavian Medical JW AB11/01/1995SE

Questions and answers

When was 3 in 1 Automatic Tourniquet cleared by the FDA?

3 in 1 Automatic Tourniquet (K880020) received a 510(k) decision of Substantially Equivalent on March 17, 1988, 72 days after the submission was received.

What is the product code of K880020?

The FDA product code is KCY – Tourniquet, Pneumatic, a Class I (low risk) device regulated under 21 CFR 878.5910.