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LTL Medical
Model M0014 · Bioteque Taiwan Ltd. · DI 04719894436487
HHK — Curette, Suction, Endometrial (And Accessories) · Class II · 21 CFR 884.1175
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)
2019-11
0
1
2021-07
0
1
2021-10
0
1
2022-02
0
1
2022-03
0
1
2022-06
0
1
2022-08
0
2
2022-12
0
1
2023-02
0
2
2023-03
0
1
2024-01
0
2
2024-02
0
2
2024-03
0
2
2024-04
0
1
2024-08
0
1
2024-10
0
1
2025-01
0
1
2025-05
0
10
2025-07
0
2
2025-09
0
1
2026-01
0
2
2026-04
0
4
This device (reports/month)Average device in HHK (reports/device/month)
Regulatory clearances
K092982 SESE 2010-07-26 (k number procode)
Predicate lineage
K092982 — cited as predicate by K240434
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Bioteque Taiwan Ltd.