Product Code: FEA FDA class 1 21 CFR 876.1500

Attachment, Teaching, For Endoscope

Gastroenterology, Urology

The Teaching Attachment for Endoscope (product code FEA) is an accessory that mounts on an endoscope to allow a second observer, such as a student or assistant, to simultaneously view the endoscopic image for training and educational purposes. It is an FDA Class 1 device (lowest risk), subject only to general controls with no premarket notification required. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

510(k)s
2
FEI Numbers
8
Registration Numbers
8
Unique Applicants
2
Years Active
14

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Basic Information

Product Code
FEA
Device Class
FDA class 1
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Review Panel
GU
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K935247 JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER
K791635 AO TEACHING ATTACHMENT, MODEL TA-1

FEI Numbers

This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.