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BE-ST NIM PAK Needle Bevel
Model PK1006 · Lacey Manufacturing Company, LLC · DI 00853508002270
PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820
UDILibrary device dossier · generated 2026-09-06 · 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)
2019-03
0
2
2019-09
0
2
2019-11
0
2
2019-12
0
1
2020-05
0
1
2021-04
0
2
2021-05
0
2
2021-07
0
1.5
2021-08
0
2
2021-10
0
6
2021-11
0
2
2022-02
0
2
2022-03
0
1.5
2022-04
0
3
2022-05
0
2
2022-07
0
4
2022-08
0
1.75
2022-09
0
1.33
2022-10
0
4
2022-11
0
4
2022-12
0
3.5
2023-01
0
1
2023-03
0
3.33
2023-05
0
2
2023-08
0
2
2023-09
0
2
2023-10
0
4
2023-11
0
2
2023-12
0
2
2024-01
0
2
2024-02
0
2
2024-07
0
2
2024-10
0
2
2025-04
0
1
2025-05
0
1
2025-07
0
4
2025-08
0
2
2025-12
0
4
2026-01
0
3
2026-02
0
2
2026-03
0
1.5
2026-04
0
2
2026-05
0
2
This device (reports/month)Average device in PDQ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Lacey Manufacturing Company, LLC
VAI 2016-04-19 Lacey Manufacturing Company Llc · 1 citations