Scissors, Umbilical
The Umbilical Scissors are a simple surgical cutting instrument designed specifically for cutting the umbilical cord during or after delivery, with blade geometry suited to the structure and consistency of the umbilical cord. They are classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDJ under regulation 21 CFR 884.4520 in the Obstetrics/Gynecology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- HDJ
- Device Class
- FDA class 1
- Regulation Number
- 884.4520
- 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 |
|---|---|---|---|---|
| K890389 | UMBILICAL SCISSORS | Feb 13, 1989 | Substantially Equivalent | Kinetic Medical Products |
FEI Numbers
This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.