Medical Device
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OXLClass II

Mesh, Surgical, Absorbable, Organ Support

21 CFR 878.3300 / General, Plastic Surgery

OXL is the FDA product code for Mesh, Surgical, Absorbable, Organ Support, 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 organ support". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OXL
Device name
Mesh, Surgical, Absorbable, Organ Support
FDA definition
For reinforcement of soft tissue where weakness exists during organ support.
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 OXL.