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Decortication Rasp - Straight

Model 3D-D05-04 · Surgentec, LLC · DI 00858406007402

HTR — Rasp · 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.

12342019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 1/device2025-01: 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 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 2/device0103060710030601040912010304050610120104091112010306071001070802030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0303
2019-0602
2019-0701
2019-1003
2020-0303
2020-0601
2021-0101
2021-0401
2021-0901
2021-1202
2022-0101
2022-0301.5
2022-0402
2022-0501
2022-0604
2022-1002
2022-1201
2023-0102
2023-0401
2023-0901
2023-1101
2023-1201
2024-0102
2024-0301
2024-0601
2024-0703
2024-1001
2025-0101
2025-0704
2025-0801
2026-0201
2026-0302
2026-0503
2026-0602
This device (reports/month)Average device in HTR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K201900 — cites (transitively): K200431 (d1), K170675 (d2), K142611 (d3), K142661 (d3), K161568 (d3), K130943 (d4), K132699 (d4), K121476 (d4), K141245 (d4), K063091 (d5), K131007 (d5) — cited as predicate by K240086

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