Print-ready dossier — use your browser's print dialog to save as PDF.
Acclarent
Model GC070CRF · Provision · DI B504GSGC070CRF0
KDC — Instrument, Surgical, Disposable · Class I · 21 CFR 878.4800
UDILibrary device dossier · generated 2026-09-11 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2020-09
0
1
2020-11
0
2
2021-01
0
1
2022-01
0
1
2022-04
0
1
2022-11
0
3
2023-03
0
3
2023-04
0
1
2023-09
0
1
2023-11
0
3
2024-05
0
2
2024-10
0
2
2024-12
0
2
2025-06
0
3
2025-09
0
4
2025-12
0
2
2026-02
0
2
2026-03
0
1
2026-04
0
2.33
2026-05
0
2
This device (reports/month)Average device in KDC (reports/device/month)