Clamp And Cutter, Umbilical
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).
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152350 | Regular and Special Umbilical Cord Clamp and Cutter | Jun 28, 2016 | Substantially Equivalent | Ningbo Feite Medical Device Co., Ltd. |
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.