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ACTEON
Model TIP BS4 M+ STERILE · SATELEC · DI 03609820879789
JDX — Instrument, Surgical, Sonic And Accessory/Attachment · Class II · 21 CFR 888.4580
UDILibrary device dossier · generated 2026-09-16 · 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.
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
2.67
2019-02
0
2
2019-05
0
2
2019-07
0
2
2019-10
0
1.5
2020-02
0
2
2020-07
0
1
2020-08
0
2
2021-03
0
2
2021-04
0
1.67
2021-06
0
1
2021-12
0
1
2022-04
0
1
2022-10
0
1
2023-01
0
2
2023-08
0
2
2024-01
0
2
2024-05
0
2
2024-07
0
1
2025-01
0
1
2025-03
0
1
2025-04
0
1
2026-03
0
2
2026-05
0
1
This device (reports/month)Average device in JDX (reports/device/month)
Regulatory clearances
K163610 SESE 2017-05-19 (k number procode)
Predicate lineage
K163610 — cites (transitively): K091331 (d1), K100410 (d1), K043310 (d2), K083284 (d2), K091252 (d2) — cited as predicate by K243280
Lineage extracted from public 510(k) summary text (heuristic).