FDA product code · Gastroenterology and urology

Needle And Needle Set, Gastro-Urology, Reprocessed

Name: FDA decisions, review times, recalls and adverse event reports for product code NMX
Creator: 510(k) Report

NMXClass II21 CFR 876.1075510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of NMX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NMX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NMX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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Other codes under 21 CFR 876.1075.

FCK Instrument, Biopsy, Suction FFF Cover, Biopsy Forceps KNW Instrument, Biopsy NLS Instrument, Biopsy, Reprocessed FCF Instrument, Biopsy, Mechanical, Gastrointestinal FCI Punch, Biopsy FCG Biopsy Needle POZ Biopsy Needle Kit NON Forceps, Biopsy, Non-Electric, Reprocessed FCL Forceps, Biopsy, Non-Electric QHC Instrument, Biopsy, Core, Soft Tissue, Female…PRV Gastro-Urology Biopsy Kit