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AVANOS
Model PMP-100-N · Avanos Medical, Inc. · DI 00193493303939
GXI — Probe, Radiofrequency Lesion · Class II · 21 CFR 882.4725
UDILibrary device dossier · generated 2026-09-11 · 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 (2)
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.
Injury: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-03
0
2
2019-04
0
1.4
2019-05
0
2.63
2019-06
0
3
2019-07
0
4.33
2019-08
0
10.2
2019-09
0
1.33
2019-10
0
5.25
2019-11
0
8.67
2019-12
0
1.25
2020-02
0
2
2020-03
0
4
2020-05
0
2
2020-07
0
1.5
2020-08
0
3
2020-09
0
1.8
2020-10
0
1.5
2020-11
0
1
2020-12
0
3.33
2021-01
0
1.33
2021-02
0
1.5
2021-04
0
3
2021-05
0
1.25
2021-06
0
1.43
2021-07
0
2
2021-08
0
1
2021-09
0
2
2021-10
0
1.5
2021-11
0
3
2022-01
0
1.5
2022-02
0
2
2022-03
0
2
2022-04
0
2
2022-05
0
2
2022-06
0
10
2022-07
0
1.5
2022-09
0
5.5
2022-10
0
2
2022-11
2
1.67
2022-12
0
1.6
2023-02
0
2
2023-03
0
1.25
2023-04
0
2
2023-05
0
2
2023-06
0
2
2023-07
0
2
2023-08
0
2
2023-09
0
4
2023-10
0
1.8
2023-11
0
1.25
2023-12
0
1.5
2024-01
0
2.25
2024-02
0
1.67
2024-03
0
2.25
2024-04
0
2
2024-05
0
2
2024-06
0
1
2024-07
0
2.5
2024-08
0
4
2024-09
0
1.5
2024-10
0
2.25
2024-12
0
1.67
2025-01
0
2
2025-02
0
3.75
2025-03
0
5
2025-04
0
3
2025-05
0
3
2025-06
0
3.5
2025-07
0
1.75
2025-08
0
4.4
2025-09
0
2
2025-10
0
1.4
2025-11
0
3.33
2025-12
0
2.4
2026-01
0
3
2026-02
0
1.83
2026-03
0
1.89
2026-04
0
3
2026-05
0
1.56
2026-06
0
3.17
This device (reports/month)Average device in GXI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K002389 — cited as predicate by K181864, K192491
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Avanos Medical, Inc.
Warning Letter 2013-04-10 Avanos Medical, Inc.
Warning Letter 2013-04-10 Avanos Medical, Inc.
Warning Letter 2008-12-22 Avanos Medical, Inc.
Warning Letter 2008-12-22 Avanos Medical, Inc.
VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
VAI 2023-12-15 Avanos Medical, Inc. · 3 citations
VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
VAI 2018-10-02 Avanos Medical, Inc. · 1 citations
VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
VAI 2016-07-29 Avanos Medical, Inc. · 1 citations
NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
NAI 2014-11-05 Avanos Medical, Inc. · 0 citations
VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
VAI 2014-03-07 Avanos Medical, Inc. · 4 citations
NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
NAI 2013-12-10 Avanos Medical, Inc. · 0 citations
OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
OAI 2013-01-04 Avanos Medical, Inc. · 6 citations
OAI 2012-10-31 Avanos Medical, Inc. · 10 citations
OAI 2012-10-31 Avanos Medical, Inc. · 10 citations