SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING— 510(k) K971613

Substantially Equivalent

Technical Products, Inc.

FDA 510(k) clearance K971613 for SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING, Substantially Equivalent on 1997-05-22. Applicant: Technical Products, Inc..

Clearance details

Applicant: Technical Products, Inc.
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1997-05-02
Decision date: 1997-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Decatur, GA, US

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.