3 IN 1 AUTOMATIC TOURNIQUET— 510(k) K880020

Name: FDA 510(k) clearance K880020
Creator: U.S. Food and Drug Administration
Published: 1988-03-17

Substantially Equivalent

Systematics Mfg. & Tool Co., Inc.

FDA 510(k) clearance K880020 for 3 IN 1 AUTOMATIC TOURNIQUET, Substantially Equivalent on 1988-03-17. Applicant: Systematics Mfg. & Tool Co., Inc.. Device class: 1.

Clearance details

Applicant: Systematics Mfg. & Tool Co., Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1988-01-05
Decision date: 1988-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bohemia, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCY

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K202919 — ATS 5000 Automatic Tourniquet Instrument2021-05-20
K162365 — T-Cuff2017-02-16
K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM2013-08-09
K112874 — EZ VEIN INFLATABLE TOURNIQUET2011-10-17
K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C0700022007-06-07

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.