Hystero Kit
by Zinnanti Surgical Instruments, Inc. 510(k)
Active
510(k) K882054
Overview
The Hystero Kit is a Uterine Elevator (product code HDP), a surgical instrument designed to assist in the dilation and elevation of the uterine cervix during gynecological procedures. It is classified under 21 CFR 884.4530 and falls within the Obstetrics/Gynecology specialty. This device is intended for use in controlled surgical settings where precise cervical manipulation is required, such as during hysteroscopic or dilation and curettage (D&C) procedures.
The Hystero Kit is supplied as a reusable surgical instrument and is regulated under FDA 510(k) clearance K882054, with a decision of Substantially Equivalent (SESE). It is intended for use in sterile environments and must be properly cleaned, sterilized, and maintained according to manufacturer guidelines. No specific MRI safety information is provided, and the kit’s components must comply with applicable surgical standards for reuse. The device was originally submitted in 1988 and remains authorized under the traditional 510(k) pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882054 | Date29 Sep 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HDP
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent