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Castroviejo Micro Needle Holder Round Handle

Model 6006-56-3 · SCANLAN INTERNATIONAL INC · DI 00846159025668

FHQ — Holder, Needle, Gastroenterologic · Class I · 21 CFR 876.4730

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.

358102019-01: 0 reports for this device; peer average 10/device2019-02: 0 reports for this device; peer average 10/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 7/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 10/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 7/device2019-12: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 4/device2022-03: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 3.5/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 1/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 3/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 6/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 7/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2/device01020304050607080910111202030405060709101112020405070901020308091012010203040710111202030405060709101201030406071201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01010
2019-02010
2019-0301
2019-0407
2019-0501
2019-0603
2019-0702
2019-08010
2019-0901.5
2019-1001
2019-1107
2019-1202
2020-0202
2020-0303
2020-0402
2020-0502
2020-0602
2020-0703
2020-0901
2020-1001
2020-1101
2020-1203
2021-0201
2021-0403
2021-0504
2021-0701
2021-0902
2022-0101
2022-0204
2022-0301
2022-0801
2022-0903.5
2022-1002
2022-1201
2023-0101
2023-0203
2023-0302
2023-0403
2023-0701.5
2023-1002
2023-1103
2023-1202
2024-0202
2024-0303
2024-0402
2024-0506
2024-0601
2024-0707
2024-0903
2024-1006
2024-1201
2025-0102
2025-0301
2025-0404
2025-0602
2025-0704
2025-1201
2026-0101
2026-0301
2026-0401
2026-0502
This device (reports/month)Average device in FHQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — SCANLAN INTERNATIONAL INC

  • NAI 2019-08-15 Scanlan International, Inc. · 0 citations
  • NAI 2019-08-15 Scanlan International, Inc. · 0 citations
  • NAI 2016-02-03 Scanlan International, Inc. · 0 citations
  • NAI 2016-02-03 Scanlan International, Inc. · 0 citations
  • NAI 2012-10-17 Scanlan International, Inc. · 0 citations
  • NAI 2012-10-17 Scanlan International, Inc. · 0 citations
  • NAI 2010-06-22 Scanlan International, Inc. · 0 citations
  • NAI 2010-06-22 Scanlan International, Inc. · 0 citations