Product Code: FFY FDA class 1 21 CFR 876.1500

Adaptor, Bulbs, Miscellaneous, For Endoscope

Gastroenterology, Urology

The Miscellaneous Bulb Adaptor for Endoscope is a fitting that connects various bulb-type attachments to an endoscope, enabling customization of the optical or illumination configuration. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FFY, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology medical specialty.

510(k)s
2
FEI Numbers
75
Registration Numbers
75
Unique Applicants
2
Years Active
4

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Basic Information

Product Code
FFY
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
K932128 CMI E-Z FLO BULB P.N. 701
K900781 WORKING CHANNEL VALVE

FEI Numbers

This FDA classification entry is associated with 75 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 75 registration numbers. Click on an entry to view related FDA registrations.