K241111
- 510(k) number
- K241111
- Device name
- AMT Suture Passer
- Applicant
- Applied Medical Technology, Inc. OH · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-07-05
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241111.pdf
Official FDA record: K241111
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.