K231603
- 510(k) number
- K231603
- Device name
- Standard Staple-Line Reinforcement (SSLR23)
- Applicant
- Standard Bariatrics, Inc. OH · US
- Product code
- OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcemen
- Decision date
- 2023-10-06
- Date received
- 2023-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231603.pdf
Official FDA record: K231603
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.