K232701
- 510(k) number
- K232701
- Device name
- Guardenia (GAR-1)
- Applicant
- Advanced Surgical Concepts IE
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2023-09-29
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232701.pdf
Official FDA record: K232701
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.