OWUClass II

Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia

21 CFR 878.3300 / General, Plastic Surgery

OWU is the FDA product code for Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OWU
Device name: Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
FDA definition: For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
Regulation: 21 CFR 878.3300
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OWU.

Recent clearances

Product code OWU

FDA records hold no clearances under product code OWU.

Recent recalls

Product code OWU

FDA records show no recalls under product code OWU.

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)