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Aspen® Flexible Light Handle Adapter

Model LT-9580 · ASPEN SURGICAL PRODUCTS, INC. · DI 00887761008984

FTA — Light, Surgical, Accessories · Class II · 21 CFR 878.4580

UDILibrary device dossier · generated 2026-09-12 · 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.

61218242019-08: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2020-12: 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 3/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 23.5/device2023-03: 0 reports for this device; peer average 15/device2023-04: 0 reports for this device; peer average 6/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 9/device2024-01: 0 reports for this device; peer average 8.67/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 9/device2024-04: 0 reports for this device; peer average 3.5/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 2.67/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.33/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 6/device2026-01: 0 reports for this device; peer average 6/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 4.4/device2026-04: 0 reports for this device; peer average 5.33/device2026-05: 0 reports for this device; peer average 2.2/device2026-06: 0 reports for this device; peer average 4/device08040912050709111202070102030405060708100102030405060910010203040508101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0802
2020-0402
2020-0901
2020-1202
2021-0502
2021-0703
2021-0901
2021-1103
2021-1201
2022-0201
2022-0701
2023-0102
2023-02023.5
2023-03015
2023-0406
2023-0502
2023-0601
2023-0701
2023-0801
2023-1009
2024-0108.67
2024-0201
2024-0309
2024-0403.5
2024-0501
2024-0602
2024-0901
2024-1001
2025-0103
2025-0202.67
2025-0301
2025-0401.5
2025-0501.5
2025-0801.33
2025-1001.5
2025-1101
2025-1206
2026-0106
2026-0201.5
2026-0304.4
2026-0405.33
2026-0502.2
2026-0604
This device (reports/month)Average device in FTA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ASPEN SURGICAL PRODUCTS, INC.

  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • VAI 2017-11-08 Aspen Surgical Products, Inc. · 5 citations
  • NAI 2017-03-02 Aspen Surgical Products Inc · 0 citations
  • NAI 2015-11-03 Aspen Surgical Puerto Rico Corp. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2015-02-11 Aspen Surgical Products, Inc. · 0 citations
  • NAI 2014-07-01 Aspen Surgical Products Inc · 0 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • VAI 2013-02-15 Aspen Surgical Products, Inc. · 1 citations
  • NAI 2012-09-28 Aspen Surgical Products Inc · 0 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations
  • VAI 2010-02-26 Aspen Surgical Products, Inc. · 4 citations