FDA product code · General and plastic surgery

Material, External Aesthetic Restoration, No Adhesive

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

NOKClass I21 CFR 878.3800510(k) exempt0 decisions0 recalls

FDA lists NOK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

external aesthetic restoration prosthesis

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, general and plastic surgery panel

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

Planning a device in NOK? 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 878.3800.

GBI Material, External Aesthetic Restoration, Used…KCZ Prosthesis, Breast, External, Used With Adhesive NOJ Prosthesis, Breast, External, No Adhesive