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4K UHD Laparoscope

Model 4K5545LR · Scivita Medical Technology Co., Ltd. · DI 06971381252156

GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500

IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600

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.

71421282019-01: 0 reports for this device; peer average 2.56/device2019-02: 0 reports for this device; peer average 3.56/device2019-03: 0 reports for this device; peer average 3.06/device2019-04: 0 reports for this device; peer average 3.9/device2019-05: 0 reports for this device; peer average 2.56/device2019-06: 0 reports for this device; peer average 3.54/device2019-07: 0 reports for this device; peer average 2.48/device2019-08: 0 reports for this device; peer average 2.46/device2019-09: 0 reports for this device; peer average 2.49/device2019-10: 0 reports for this device; peer average 2.72/device2019-11: 0 reports for this device; peer average 2.1/device2019-12: 0 reports for this device; peer average 2.41/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 2.75/device2020-03: 0 reports for this device; peer average 2.27/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 0 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.72/device2020-08: 0 reports for this device; peer average 4.17/device2020-09: 0 reports for this device; peer average 4.29/device2020-10: 0 reports for this device; peer average 3.82/device2020-11: 0 reports for this device; peer average 4.24/device2020-12: 0 reports for this device; peer average 3.72/device2021-01: 0 reports for this device; peer average 3.79/device2021-02: 0 reports for this device; peer average 3.68/device2021-03: 0 reports for this device; peer average 4.65/device2021-04: 0 reports for this device; peer average 4.72/device2021-05: 0 reports for this device; peer average 4.13/device2021-06: 0 reports for this device; peer average 4.47/device2021-07: 0 reports for this device; peer average 3.86/device2021-08: 0 reports for this device; peer average 3.86/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 3.83/device2021-11: 0 reports for this device; peer average 3.49/device2021-12: 0 reports for this device; peer average 4.44/device2022-01: 0 reports for this device; peer average 4.35/device2022-02: 0 reports for this device; peer average 4.78/device2022-03: 0 reports for this device; peer average 5.3/device2022-04: 0 reports for this device; peer average 6.27/device2022-05: 0 reports for this device; peer average 5.36/device2022-06: 0 reports for this device; peer average 6.05/device2022-07: 0 reports for this device; peer average 6.08/device2022-08: 0 reports for this device; peer average 6.14/device2022-09: 0 reports for this device; peer average 5.43/device2022-10: 0 reports for this device; peer average 7.22/device2022-11: 0 reports for this device; peer average 11.5/device2022-12: 0 reports for this device; peer average 11.34/device2023-01: 0 reports for this device; peer average 11.57/device2023-02: 0 reports for this device; peer average 8.73/device2023-03: 0 reports for this device; peer average 14.92/device2023-04: 0 reports for this device; peer average 9.63/device2023-05: 0 reports for this device; peer average 11.2/device2023-06: 0 reports for this device; peer average 11.52/device2023-07: 0 reports for this device; peer average 9.29/device2023-08: 0 reports for this device; peer average 9.63/device2023-09: 0 reports for this device; peer average 10.8/device2023-10: 0 reports for this device; peer average 10.57/device2023-11: 0 reports for this device; peer average 10.78/device2023-12: 0 reports for this device; peer average 10.66/device2024-01: 0 reports for this device; peer average 10.42/device2024-02: 0 reports for this device; peer average 13.34/device2024-03: 0 reports for this device; peer average 10.04/device2024-04: 0 reports for this device; peer average 10.04/device2024-05: 0 reports for this device; peer average 8.44/device2024-06: 0 reports for this device; peer average 10.62/device2024-07: 0 reports for this device; peer average 9.87/device2024-08: 0 reports for this device; peer average 11.19/device2024-09: 0 reports for this device; peer average 10.77/device2024-10: 0 reports for this device; peer average 11.61/device2024-11: 0 reports for this device; peer average 8.44/device2024-12: 0 reports for this device; peer average 8.67/device2025-01: 0 reports for this device; peer average 8.01/device2025-02: 0 reports for this device; peer average 11.11/device2025-03: 0 reports for this device; peer average 9.2/device2025-04: 0 reports for this device; peer average 11.31/device2025-05: 0 reports for this device; peer average 10.41/device2025-06: 0 reports for this device; peer average 12.08/device2025-07: 0 reports for this device; peer average 11.95/device2025-08: 0 reports for this device; peer average 20.16/device2025-09: 0 reports for this device; peer average 25.25/device2025-10: 0 reports for this device; peer average 28.04/device2025-11: 0 reports for this device; peer average 19.91/device2025-12: 0 reports for this device; peer average 8.35/device2026-01: 0 reports for this device; peer average 7.4/device2026-02: 0 reports for this device; peer average 6.83/device2026-03: 0 reports for this device; peer average 7.49/device2026-04: 0 reports for this device; peer average 7.54/device2026-05: 0 reports for this device; peer average 7.51/device2026-06: 0 reports for this device; peer average 6.82/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.56
2019-0203.56
2019-0303.06
2019-0403.9
2019-0502.56
2019-0603.54
2019-0702.48
2019-0802.46
2019-0902.49
2019-1002.72
2019-1102.1
2019-1202.41
2020-0102.55
2020-0202.75
2020-0302.27
2020-0402.54
2020-0501.98
2020-0602.78
2020-0702.72
2020-0804.17
2020-0904.29
2020-1003.82
2020-1104.24
2020-1203.72
2021-0103.79
2021-0203.68
2021-0304.65
2021-0404.72
2021-0504.13
2021-0604.47
2021-0703.86
2021-0803.86
2021-0904
2021-1003.83
2021-1103.49
2021-1204.44
2022-0104.35
2022-0204.78
2022-0305.3
2022-0406.27
2022-0505.36
2022-0606.05
2022-0706.08
2022-0806.14
2022-0905.43
2022-1007.22
2022-11011.5
2022-12011.34
2023-01011.57
2023-0208.73
2023-03014.92
2023-0409.63
2023-05011.2
2023-06011.52
2023-0709.29
2023-0809.63
2023-09010.8
2023-10010.57
2023-11010.78
2023-12010.66
2024-01010.42
2024-02013.34
2024-03010.04
2024-04010.04
2024-0508.44
2024-06010.62
2024-0709.87
2024-08011.19
2024-09010.77
2024-10011.61
2024-1108.44
2024-1208.67
2025-0108.01
2025-02011.11
2025-0309.2
2025-04011.31
2025-05010.41
2025-06012.08
2025-07011.95
2025-08020.16
2025-09025.25
2025-10028.04
2025-11019.91
2025-1208.35
2026-0107.4
2026-0206.83
2026-0307.49
2026-0407.54
2026-0507.51
2026-0606.82
This device (reports/month)Average device in GCJ, IZI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K221252 — cites (transitively): K182606 (d1), K203255 (d1), K150956 (d2), K161792 (d2), K150377 (d2), K150633 (d2), K200216 (d2), K113203 (d3), K923982 (d3), K091515 (d3), K141077 (d3), K142310 (d3), K080560 (d3), K151011 (d3), K941541 (d3), K981751 (d3), K102379 (d4), K124031 (d4), K132785 (d4), K910132 (d4), K102059 (d4), K111425 (d4), K083155 (d5), K943304 (d5), K943307 (d5), K061313 (d5), K062049 (d5), K080948 (d5), K100584 (d5), K983566 (d5), K051645 (d6) — cited as predicate by K223557

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

Manufacturer compliance record — Scivita Medical Technology Co., Ltd.

  • VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations
  • VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations