TECNADYNE T-CUFF— 510(k) K942303

Name: FDA 510(k) clearance K942303
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Technadyne Scientific, Inc.

FDA 510(k) clearance K942303 for TECNADYNE T-CUFF, Substantially Equivalent on 1994-07-20. Applicant: Technadyne Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Technadyne Scientific, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1994-05-13
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vero Beach, FL, US

Download summary PDF View on FDA.gov ↗

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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.