Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Tissue Protector, DynaFuse

Model 3100-09-0001 · Medshape, Inc. · DI M97031000900010

JEC — Component, Traction, Invasive · Class II · 21 CFR 888.3040

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.

12342019-03: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 4/device2019-09: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1.8/device2023-05: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device03050912010607121107040504011006
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301
2019-0504
2019-0901
2019-1201
2020-0103
2020-0602
2020-0701
2020-1203
2021-1101
2022-0701
2023-0401.8
2023-0501.75
2024-0401
2025-0101
2025-1001
2026-0601
This device (reports/month)Average device in JEC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K203595 — cites (transitively): K133842 (d1), K153338 (d1), K153575 (d1), K973309 (d2), K021556 (d2), K063298 (d2), K081510 (d2), K112737 (d2), K151021 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K153180 (d2), K050636 (d3), K062863 (d3), K954330 (d3) — cited as predicate by K252699, K254110

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Medshape, Inc.

  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations