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INTRODUCER SHAFT

Model 2800-514 · SONTEC INSTRUMENTS, INC. · DI B09928005140

FFO — Retractor, Self-Retaining · Class I · 21 CFR 876.4730

UDILibrary device dossier · generated 2026-09-14 · 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.

12342020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 3.5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device080903100304070902
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0802
2020-0902
2022-0302
2024-1003.5
2025-0301
2025-0401
2025-0701
2025-0901
2026-0201
This device (reports/month)Average device in FFO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — SONTEC INSTRUMENTS, INC.

  • VAI 2016-10-21 Sontec Instruments, Inc · 7 citations
  • VAI 2016-10-21 Sontec Instruments, Inc · 7 citations