Hook, Fibroid, Gynecological
The Gynecological Fibroid Hook is a manual instrument used in gynecological surgery to manipulate or retract uterine fibroid tissue during myomectomy or hysterectomy procedures, providing purchase on fibroid tissue to facilitate its dissection and removal. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HDE 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
- HDE
- 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 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.