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Follicle Aspiration Set Double Lumen
Model 17168 · Vitrolife Sweden AB · DI 07350025915418
MQE — Needle, Assisted Reproduction · Class II · 21 CFR 884.6100
UDILibrary device dossier · generated 2026-09-15 · 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)
2019-09
0
1
2019-10
0
2
2022-07
0
3
2022-09
0
1
2023-04
0
6
2023-07
0
4.67
2023-08
0
3.33
2023-10
0
5
2023-12
0
4
2024-08
0
4
2025-05
0
8
2026-06
0
2
This device (reports/month)Average device in MQE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K161970 — cites (transitively): K991273 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Vitrolife Sweden AB