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Invenio

Model TUF004 · GRI Medical & Electronic Technology Co., Ltd. · DI 16931918163949

POZ — Biopsy Needle Kit · Class II · 21 CFR 876.1075

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — GRI Medical & Electronic Technology Co., Ltd.

  • Warning Letter 2013-05-01 GRI Medical & Electronic Technology Co., Ltd.
  • NAI 2016-09-22 GRI Medical & Electronic Technology Co., Ltd. · 0 citations
  • NAI 2014-08-14 GRI Medical & Electronic Technology Co., Ltd. · 0 citations
  • OAI 2012-12-20 GRI Medical & Electronic Technology Co., Ltd. · 8 citations