OptiVu HDVD System
510(k) K001169
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001169 | Date16 May 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The OptiVu HDVD System is a laparoscope designed for general and plastic surgery applications, enabling high-definition visualization during minimally invasive procedures. It integrates advanced imaging technology to provide clear, magnified views of internal anatomical structures, supporting precise surgical interventions in gastroenterology and urology. The system is classified under the Laparoscope, General & Plastic Surgery nomenclature, adhering to regulatory standards for endoscopic devices.
This system is intended for use in surgical settings where high-resolution imaging is required, typically in laparoscopic procedures. It is supplied as a reusable medical device, with regulatory clearance granted under FDA 510(k) K001169 as substantially equivalent to predicate devices. The system is not indicated for MRI use and must be stored and handled according to manufacturer guidelines to maintain sterility and functionality. Authorized by the FDA for distribution in the United States, it falls under product code GCJ and classification II.
Questions
AI-generated answers, 1 Oct 2026
What surgical specialties is the OptiVu HDVD System designed for?
The OptiVu HDVD System is specifically engineered for general and plastic surgery applications, with particular utility in gastroenterology and urology procedures. Its high-definition imaging enhances visualization of internal anatomical structures, enabling more precise surgical interventions in minimally invasive laparoscopic settings.
Is the OptiVu HDVD System reusable or single-use?
The OptiVu HDVD System is designed as a reusable medical device. Reusability is supported by its regulatory clearance under the FDA’s 510(k) pathway, which requires adherence to strict cleaning, sterilization, and maintenance protocols to ensure safety and functionality across multiple uses.
What storage and handling guidelines must be followed for the OptiVu HDVD System?
The system must be stored and handled according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is reusable, proper cleaning, sterilization, and storage in a controlled environment are critical to prevent contamination and ensure longevity. Avoid exposure to MRI fields, as the device is not MRI-compatible.
What distinguishes the OptiVu HDVD System from other laparoscopes?
The OptiVu HDVD System stands out due to its advanced high-definition imaging technology, which provides magnified and clear views of internal structures during laparoscopic procedures. This clarity supports more precise surgical interventions, particularly in complex cases within general, plastic, gastroenterology, and urology specialties.
Can the OptiVu HDVD System be used in MRI environments?
No, the OptiVu HDVD System is explicitly not indicated for MRI use. Its design and materials are not compatible with magnetic resonance imaging environments, so it must be used in non-MRI settings to avoid potential damage or interference.