BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK— 510(k) K033862

Name: FDA 510(k) clearance K033862
Creator: U.S. Food and Drug Administration
Published: 2005-02-14

Substantially Equivalent

Bioteque Corp.

FDA 510(k) clearance K033862 for BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK, Substantially Equivalent on 2005-02-14. Applicant: Bioteque Corp.. Device class: 2.

Clearance details

Applicant: Bioteque Corp.
Product code: Code FGE
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2003-12-12
Decision date: 2005-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.