Scissors, Episiotomy
The Episiotomy Scissors are a gynecological surgical instrument used to make a controlled incision in the perineum and posterior vaginal wall during childbirth to enlarge the vaginal opening and facilitate delivery, reducing the risk of uncontrolled tearing. They are classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDK 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
- HDK
- Device Class
- FDA class 1
- Regulation Number
- 884.4520
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.