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BMAN Solid Diamond Needle Kit

Model SR07-1101 · Surgentec, LLC · DI 00810131880958

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.

23562019-03: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 6/device2021-11: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 1.75/device2022-09: 0 reports for this device; peer average 1.33/device2022-10: 0 reports for this device; peer average 4/device2022-11: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 3.5/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3.33/device2023-05: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device03091112050405070810110203040507080910111201030508091011120102071004050708120102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0902
2019-1102
2019-1201
2020-0501
2021-0402
2021-0502
2021-0701.5
2021-0802
2021-1006
2021-1102
2022-0202
2022-0301.5
2022-0403
2022-0502
2022-0704
2022-0801.75
2022-0901.33
2022-1004
2022-1104
2022-1203.5
2023-0101
2023-0303.33
2023-0502
2023-0802
2023-0902
2023-1004
2023-1102
2023-1202
2024-0102
2024-0202
2024-0702
2024-1002
2025-0401
2025-0501
2025-0704
2025-0802
2025-1204
2026-0103
2026-0202
2026-0301.5
2026-0402
2026-0502
This device (reports/month)Average device in PDQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K240664 — cites (transitively): K131157 (d1), K190163 (d1), K050795 (d2), K171807 (d2), K140400 (d3), K122845 (d4), K123307 (d4), K102235 (d5), K050438 (d5), K122742 (d5), K002858 (d6), K013823 (d6), K043473 (d6), K063428 (d6), K951725 (d6), K033621 (d6) — cited as predicate by K243945

K243945 — cites (transitively): K131157 (d1), K170539 (d1), K190163 (d1), K240664 (d1), K050795 (d2), K152474 (d2), K171807 (d2), K071732 (d3), K140400 (d3), K122845 (d4), K123307 (d4), K102235 (d5), K050438 (d5), K122742 (d5), K002858 (d6), K013823 (d6), K043473 (d6), K063428 (d6), K951725 (d6), K033621 (d6)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Surgentec, LLC

  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations