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 codeNo registered establishment in MDM’s records lists product code OXL.
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