Manzi Cleaner System
510(k) K043314
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043314 | Date20 Jun 2005 | 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- Withdrawn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
- NVE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Manzi Cleaner System is an Automated Washer, Cleaner for Endoscopes (NVE Product Code), designed for the mechanical cleaning of bronchoscopes. It employs a proprietary push-pull agitation system and anionic detergent (MD10) to remove bioburden and residues from flexible endoscopes in a healthcare setting.
This device operates as a standalone, non-sterile system intended for use in clinical environments such as gastroenterology and urology. It consists of a stainless steel processing chamber, agitation pump, and movable frame, with disposable water filters and reusable trays as accessories. The system is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K043314) for substantial equivalence.
Other devices from Langford IC Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of bronchoscopes can the Manzi Cleaner System clean, and how does its proprietary push-pull agitation system work?
The Manzi Cleaner System is specifically designed for the mechanical cleaning of flexible bronchoscopes, which are commonly used in gastroenterology and urology procedures. Its proprietary push-pull agitation system creates a dynamic cleaning action by alternately pushing and pulling cleaning solution through the scope’s channels, helping to dislodge bioburden and residues more effectively than static methods. This agitation, combined with the anionic detergent (MD10), ensures thorough cleaning of the scope’s internal and external surfaces.
Is the Manzi Cleaner System intended for single-use or reusable components, and what accessories are included?
The Manzi Cleaner System itself is a reusable, standalone device built with a stainless steel processing chamber and agitation pump. However, it includes disposable water filters and reusable trays as accessories to facilitate cleaning cycles. The disposable filters help maintain water quality during use, while the trays provide a dedicated space for placing bronchoscopes during the automated cleaning process.
How should the Manzi Cleaner System be stored, and is it designed for sterile processing?
The Manzi Cleaner System is not sterile and is designed for use in clinical environments where endoscopes are processed. It should be stored in a clean, dry, and controlled environment to prevent contamination. Since it is a non-sterile washer-cleaner, it is not intended for creating sterile endoscopes—sterilization would require additional high-level disinfection or sterilization steps after cleaning. Always follow manufacturer guidelines for maintenance and cleaning of the system itself.
What regulatory pathway does the Manzi Cleaner System follow, and which advisory committees were involved in its review?
The Manzi Cleaner System follows the FDA 510(k) clearance pathway, specifically under the Traditional review process for substantial equivalence. It was reviewed by the Gastroenterology and Urology (GU) Advisory Committee as part of the Hemodialysis and Urology (HO) Review Panel, reflecting its intended use in these clinical specialties. The device holds a clearance number (K043314) and is classified as a Class II medical device under FDA regulations.