Monoscopy Brand 5 mm Locking Trocar Sleeve
by Dexide, Inc. 510(k)
Active
510(k) K896205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896205 | Date22 Mar 1990 | 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- Withdrawn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
- GCI
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
This is a laryngoscope and endoscope device, specifically a 5 mm locking trocar sleeve, as defined by its device name and classification. It is a Class II medical device under FDA regulation, identified by product code GCI and associated with the gastroenterology and urology medical specialties.
The device was cleared via the FDA 510(k) pathway under traditional review, with clearance granted on March 22, 1990 (K896205). It is manufactured by Dexide, Inc. in Fort Worth, Texas, and is supplied as a non-sterile, reusable component intended for use in endoscopic procedures.
Other devices from Dexide, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the MONOSCOPY BRAND 5 MM Locking Trocar Sleeve used for?
It is a component used in endoscopic procedures, specifically designed as a 5 mm locking trocar sleeve for laryngoscope and endoscope applications in gastroenterology and urology specialties, providing access during minimally invasive interventions.
Is the MONOSCOPY BRAND 5 MM Locking Trocar Sleeve sterile or non-sterile, and is it intended for single-use or reuse?
The device is supplied as a non-sterile, reusable component, meaning it must be cleaned and sterilized by the user before each use and is not intended for single-use disposal.
Who manufactures the MONOSCOPY BRAND 5 MM Locking Trocar Sleeve and where is it made?
The device is manufactured by Dexide, Inc. in Fort Worth, Texas, United States, as indicated in the FDA 510(k) clearance documentation and establishment registration details.