DMI Tocar and Cannula System
by Diversified Medical Instruments, Inc. 510(k)
Active
510(k) K926078
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926078 | Date17 May 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 27 Sep 2026
The DMI Tocar and Cannula System is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. It is classified under product code GCJ and was determined to be substantially equivalent to a predicate device.
The system was cleared via the traditional 510(k) pathway (K926078) by the FDA on May 17, 1993, following review by the Gastroenterology and Urology advisory committees. It is manufactured by Diversified Medical Instruments, Inc. and is intended for use in clinical settings requiring endoscopic access.
Other devices from Diversified Medical Instruments, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the DMI Tocar and Cannula System used for?
The DMI Tocar and Cannula System is used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals in clinical settings requiring endoscopic access.
How was the DMI Tocar and Cannula System cleared for market?
The system was cleared via the traditional 510(k) pathway (K926078) by the FDA on May 17, 1993, following review by the Gastroenterology and Urology advisory committees, and was determined to be substantially equivalent to a predicate device.
Who manufactures the DMI Tocar and Cannula System and where are they located?
The DMI Tocar and Cannula System is manufactured by Diversified Medical Instruments, Inc., located at 4519 Taraley Ct., Ellicott City, MD 21042, United States.