SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A— 510(k) K925434

Substantially Equivalent

Kretz Technik

FDA 510(k) clearance K925434 for SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A, Substantially Equivalent on 1993-09-30. Applicant: Kretz Technik.

Clearance details

Applicant: Kretz Technik
Product code: Code ITX
Advisory panel: Radiology
Date received: 1992-10-28
Decision date: 1993-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.