Atlas FDA

MANZI CLEANER SYSTEM

FDA 510(k) clearance K043314 · decided 2005-06-20

Clearance details

K-number
K043314
Device name
MANZI CLEANER SYSTEM
Applicant
Langford IC Systems, Inc.
Decision
Substantially Equivalent
Date received
2004-12-01
Decision date
2005-06-20
Days to decision
201 days
Clearance type
Traditional
Product code
NVE
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Tucson, AZ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Langford IC Systems

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849)Steris2022-09-30
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222543)Steris2022-08-25
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (K203199)STERIS Corporation2020-12-01
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K200577)STERIS Corporation2020-04-03
RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K190081)STERIS Corporation2019-08-21
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (K073112)Intuitive Surgical, Inc.2008-08-01
MODIFICATION TO SYSTEM 83 PLUS (K983017)Custom Ultrasonics1998-09-22
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (K871712)Machida America, Inc.1988-01-14
KEYMED FIBERSCOPE AUTO DISINFECTOR (K861821)Keymed, Inc.1987-02-12
OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES (K862402)Medivators, Inc.1987-02-03
AUTOMATIC ENDOSCOPE (K832458)American Endoscopy, Inc.1983-10-20

Recalls involving this device

No recalls on record reference this clearance.