K242606
- 510(k) number
- K242606
- Device name
- Nuvis® Wireless HD Camera System (Nuvis-2K)
- Applicant
- Integrated Endoscopy, Inc. CA · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-11-20
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K242606.pdf
Official FDA record: K242606
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.