K243750
- 510(k) number
- K243750
- Device name
- SimpleStitch Suturing System
- Applicant
- Envision Endoscopy MA · US
- Product code
- OCW — Endoscopic Tissue Approximation Device
- Decision date
- 2025-04-17
- Date received
- 2024-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243750.pdf
Official FDA record: K243750
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.