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Big Easy® Piston

Model 1156601 · MEDTRONIC XOMED, INC. · DI 00763000036553

ETA — Replacement, Ossicular Prosthesis, Total · Class II · 21 CFR 874.3495

ETB — Prosthesis, Partial Ossicular Replacement · Class II · 21 CFR 874.3450

UDILibrary device dossier · generated 2026-09-07 · 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.

12232019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.25/device2019-05: 0 reports for this device; peer average 1.2/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.4/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device010304050809101201070808010203060710010304050806070910030608
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0401.25
2019-0501.2
2019-0801.5
2019-0901.5
2019-1001.5
2019-1201
2020-0101.4
2020-0702
2020-0801
2021-0802
2022-0101.5
2022-0201
2022-0301.5
2022-0601.67
2022-0701.5
2022-1003
2023-0102
2023-0301
2023-0401
2023-0501
2023-0801.5
2024-0601.33
2024-0702.25
2024-0901
2024-1002
2025-0302.5
2025-0601
2025-0801.5
This device (reports/month)Average device in ETA, ETB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K002897 — cited as predicate by K130512

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

Manufacturer compliance record — MEDTRONIC XOMED, INC.

  • VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
  • VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
  • VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
  • VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
  • NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
  • VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations