FDA product code · Ear, nose and throat

Crimper, Wire, Ent, Non-Sterile

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

NNNClass I21 CFR 874.3540510(k) exempt0 decisions0 recalls

FDA lists NNN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

Prosthesis modification instrument for ossicular replacement surgery; see product code JXT.

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, ear, nose and throat panel

Twenty years of NNN 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 — NNN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NNN? 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

Related product codes

Other codes under 21 CFR 874.3540.

JYB Vise, Ossicular Finger, Sterile NNR Block, Cutting, Ent, Non-Sterile JXY Jig, Piston Cutting, Ent, Sterile NNS Instrument, Prosthesis Modification For…JXT Crimper, Wire, Ent, Sterile NNO Jig, Piston Cutting, Ent, Non-Sterile JXW Die, Wire Bending, Ent, Sterile NNT Punch, Gelfoam, Non-Sterile JYA Scissors, Wire Cutting, Ent, Sterile JXS Block, Cutting, Ent, Sterile NNV Vise, Ossicular Finger, Non-Sterile NNP Die, Wire Bending, Ent, Non-Sterile