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Access Surgical® Laparoscopy

Model 38-5403 · ASPEN SURGICAL PRODUCTS, INC. · DI 00887482134139

HRR — Scissors, Orthopedic, Surgical · Class I · 21 CFR 888.4540

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.

12342020-06: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device06030407
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0604
2023-0303
2023-0403
2023-0703
This device (reports/month)Average device in HRR (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