Elevator, Uterine
The Uterine Elevator is a manual surgical instrument used in gynecological procedures to manipulate and reposition the uterus, typically to improve surgical access during laparoscopic or open procedures. It is classified as FDA Class 2 (moderate risk), meaning manufacturers must submit a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is HDP, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- HDP
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974801 | SINGLE CHANNEL BALLOON CANNULA | Jul 09, 1998 | Substantially Equivalent | Conkin Surgical Instruments , Ltd. |
| K974563 | COLPO CUP CVC-2000 | Mar 02, 1998 | Substantially Equivalent | Clinical Innovations, Inc. |
| K882054 | HYSTERO KIT | Sep 29, 1988 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K820672 | HASSON BUEC-3 | Jul 30, 1982 | Substantially Equivalent | Bivona Medical Technologies |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.