Product Code: NBZ FDA class 2 21 CFR 884.4530

Clamp And Cutter, Umbilical

Obstetrics/Gynecology

The Umbilical Clamp and Cutter is an obstetrics device used at the time of birth to clamp and cut the umbilical cord, separating the newborn from the placenta. These combined devices allow both clamping and cutting to be performed with a single instrument. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 884.4530 (Obstetrics/Gynecology specialty).

510(k)s
1
FEI Numbers
6
Registration Numbers
6
Unique Applicants
1
Years Active

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Basic Information

Product Code
NBZ
Device Class
FDA class 2
Regulation Number
884.4530
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
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 1 510(k) clearance via K numbers.

K Number Device Name
K152350 Regular and Special Umbilical Cord Clamp and Cutter

FEI Numbers

This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.