SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS— 510(k) K850503

Name: FDA 510(k) clearance K850503
Creator: U.S. Food and Drug Administration
Published: 1985-04-01

Substantially Equivalent

Turn Needle Intl., Inc.

FDA 510(k) clearance K850503 for SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS, Substantially Equivalent on 1985-04-01. Applicant: Turn Needle Intl., Inc.. Device class: 1.

Clearance details

Applicant: Turn Needle Intl., Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1985-02-08
Decision date: 1985-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K844917 — TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE1985-02-07

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.