Atlas FDA

AUTOMATIC ENDOSCOPE

FDA 510(k) clearance K832458 · decided 1983-10-20

Clearance details

K-number
K832458
Device name
AUTOMATIC ENDOSCOPE
Applicant
American Endoscopy, Inc.
Decision
Substantially Equivalent
Date received
1983-07-26
Decision date
1983-10-20
Days to decision
86 days
Clearance type
Traditional
Product code
NVE
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machin recall (Z-0628-2011)Advanced Sterilization Products2010-12-16
ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Prod recall (Z-0281-2009)Advanced Sterilization Products2008-11-07