Product Code: FHG FDA class 2 21 CFR 884.4530

Bell, Circumcision

Obstetrics/Gynecology

The Circumcision Bell is a medical device used as part of a circumcision clamp system to guide and protect the glans during surgical removal of the prepuce in male patients. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FHG, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology medical specialty.

510(k)s
2
FEI Numbers
3
Registration Numbers
3
Unique Applicants
2
Years Active
14

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Basic Information

Product Code
FHG
Device Class
FDA class 2
Regulation Number
884.4530
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
Submission Type
1

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
K911272 ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
K770873 CIRCUMCISION KIT

FEI Numbers

This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.