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

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..

Clearance details

Applicant
Turn Needle Intl., Inc.
Product code
Code KMK
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami Beach, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KMK

product code KMK
Malfunction
461
Other
1
Total
462

Source: openFDA MAUDE database, through . 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.