TIK EXTRAKTOR— 510(k) K895212

Name: FDA 510(k) clearance K895212
Creator: U.S. Food and Drug Administration
Published: 1989-09-27

Substantially Equivalent

Instruments of Sweden, Inc.

FDA 510(k) clearance K895212 for TIK EXTRAKTOR, Substantially Equivalent on 1989-09-27. Applicant: Instruments of Sweden, Inc.. Device class: 1.

Clearance details

Applicant: Instruments of Sweden, Inc.
Product code: Code HTD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1989-08-18
Decision date: 1989-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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Adverse events under product code HTD

product code HTD

Malfunction: 892
Total: 892

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.