Print-ready dossier — use your browser's print dialog to save as PDF.
4WEB Medical
Model LSTS-100404 · 4web Medical · DI 00812998047314
HTF — Curette · Class I · 21 CFR 878.4800
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-08
0
1
2019-10
0
2
2020-02
0
1
2020-04
0
3
2021-01
0
2
2021-03
0
3
2021-05
0
1
2021-06
0
1
2021-09
0
1.33
2021-12
0
3
2022-03
0
3
2022-04
0
3
2022-10
0
2
2022-11
0
2
2023-02
0
1
2023-03
0
1
2023-05
0
1
2023-06
0
2
2023-08
0
2
2023-09
0
1
2023-10
0
2
2023-12
0
2
2024-01
0
1
2024-06
0
1
2024-11
0
1
2025-01
0
1
2025-02
0
2.33
2025-04
0
4
2025-11
0
1.8
2025-12
0
3.67
2026-03
0
2
2026-06
0
1
This device (reports/month)Average device in HTF (reports/device/month)