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9" Nerve Hook
Model K-9414 · Kapp Surgical Instrument Co. · DI B033K94140
GDG — Hook, Surgical, General & Plastic Surgery · 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)
2019-08
0
1
2019-09
0
2
2020-05
0
1
2020-08
0
4
2020-09
0
1
2021-03
0
3
2021-07
0
1
2021-09
0
3
2021-10
0
6
2022-02
0
12
2022-09
0
2
2022-10
0
2
2023-02
0
2
2023-12
0
3
2024-01
0
2
2024-09
0
1
2024-10
0
1
2024-12
0
2
2025-07
0
1
2025-09
0
1
2025-12
0
1
2026-02
0
2
This device (reports/month)Average device in GDG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Kapp Surgical Instrument Co.
VAI 2018-11-16 Kapp Surgical Instrument Inc · 4 citations
NAI 2015-02-24 Kapp Surgical Instrument Inc · 0 citations
VAI 2011-03-22 Kapp Surgical Instrument Inc · 1 citations