Devin-Nestor Pneumatic Tourniquet

FDA 510(k) K780988 · Nestor Engineering Associates, Inc.

Substantially Equivalent

510(k) numberK780988

Submission

Device name
Devin-Nestor Pneumatic Tourniquet
Applicant
Nestor Engineering Associates, Inc.
Mchenry, IL, US
Received
June 14, 1978
Decision date
October 3, 1978
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

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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

More from Scandinavian Medical JW AB

510(k)DeviceDecision
K780991Parallel Blade MarkerEMF · Traditional 10/03/1978SE
K780990Stainless Steel Template · Traditional 10/03/1978SE
K780989Devin-Nestor Square KnifeEMF · Traditional 10/03/1978SE
K780992Millard Mouth GagKBN · Traditional 08/17/1978SE

Questions and answers

When was Devin-Nestor Pneumatic Tourniquet cleared by the FDA?

Devin-Nestor Pneumatic Tourniquet (K780988) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 111 days after the submission was received.

What is the product code of K780988?

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