Manzi Cleaner System
FDA 510(k) K043314 · Langford IC Systems, Inc.
510(k) numberK043314
Submission
- Device name
- Manzi Cleaner System
- Applicant
- Langford IC Systems, Inc.
Tucson, AZ, US - Received
- December 1, 2004
- Decision date
- June 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVE – Washer, Cleaner, Automated, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that…
Other 510(k)s with product code NVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…NVE · Special | Steris | 09/30/2022SE |
| K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…NVE · Special | Steris | 08/25/2022SE |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…NVE · Special | STERIS Corporation | 12/01/2020SE |
| K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…NVE · Special | STERIS Corporation | 04/03/2020SE |
| K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…NVE · Traditional | STERIS Corporation | 08/21/2019SE |
| K073112 | Da Vinci Sonicpro Cleaning System, Model 400253NVE · Traditional | Intuitive Surgical, Inc. | 08/01/2008SE |
| K983017 | Modification to System 83 PlusNVE · Special | Custom Ultrasonics | 09/22/1998SE |
| K871712 | Machida America Model AC-5000 Automatic Disinfect.NVE · Traditional | Machida America, Inc. | 01/14/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | Keymed, Inc. | 02/12/1987SE |
| K862402 | Ott Disinfector for Flexible EndoscopesNVE · Traditional | Medivators, Inc. | 02/03/1987SE |
More from Medivators, Inc.
Questions and answers
When was Manzi Cleaner System cleared by the FDA?
Manzi Cleaner System (K043314) received a 510(k) decision of Substantially Equivalent on June 20, 2005, 201 days after the submission was received.
What is the product code of K043314?
The FDA product code is NVE – Washer, Cleaner, Automated, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.