NOCClass I

Splint, Extremity, Non-Inflatable, External, Non-Sterile

21 CFR 878.3910 / General, Plastic Surgery

NOC is the FDA product code for Splint, Extremity, Non-Inflatable, External, Non-Sterile, a class I device type, regulated under 21 CFR 878.3910. FDA's definition for this code reads: "Non-inflatable extremity splint; See product code fyh". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NOC
Device name: Splint, Extremity, Non-Inflatable, External, Non-Sterile
FDA definition: Non-inflatable extremity splint; See product code fyh.
Regulation: 21 CFR 878.3910
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 163 companies shown, in name order

Recent clearances

Product code NOC

FDA records hold no clearances under product code NOC.

Recent recalls

Product code NOC

Z-0552-2018Class IIMold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.3M Company - Health Care Business / initiated 2017-11-01 / 996 units

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)