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ASPIRATION NEEDLE

Model NA-2C-1 · OLYMPUS MEDICAL SYSTEMS CORP. · DI 04953170035302

GDM — Needle, Aspiration And Injection, Reusable · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-13 · 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 (1)

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.

Death: 1

12232021-06: 1 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 3/device061101060110031105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0611
2021-1102
2022-0102
2022-0603
2023-0103
2023-1002
2024-0301
2024-1102
2025-0503
This device (reports/month)Average device in GDM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — OLYMPUS MEDICAL SYSTEMS CORP.

  • Warning Letter 2022-12-12 Olympus Medical Systems Corporation
  • Warning Letter 2018-03-09 Olympus Medical Systems Corporation
  • OAI 2022-09-09 Olympus Medical Systems Corporation · 1 citations
  • OAI 2015-04-24 Olympus Medical Systems Corporation · 2 citations