K233386
- 510(k) number
- K233386
- Device name
- Monik - Disposable Endoscopic Trocar
- Applicant
- M/s. Meril Endo Surgery Private Limited. IN
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-05-24
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K233386.pdf
Official FDA record: K233386
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.