Remover, Intrauterine Device, Contraceptive, Hook-Type
The Hook-Type Intrauterine Device Remover is a simple instrument designed to grasp and extract an intrauterine contraceptive device from the uterine cavity, particularly in cases where the retrieval string is absent or inaccessible. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HHF, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. No special risk flags apply.
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Basic Information
- Product Code
- HHF
- Device Class
- FDA class 1
- Regulation Number
- 884.4530
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926541 | IUD HOOKS | Feb 24, 1994 | Substantially Equivalent | Thomasville Medical Assoc. |
| K891030 | IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR | Mar 17, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K842295 | INTRAUTERINE DEVICE REMOVER | Oct 12, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K831568 | RELIANCE TEMPO OPHTH. INSTR STAND | Jun 30, 1983 | Substantially Equivalent | F. & F. Koenigkramer |
| K820115 | EMMETT IUD THREAD RETREIVER | Feb 05, 1982 | Substantially Equivalent | Proto-Med, Inc. |
| K811761 | THE EMMETT IUD THREAD RETRIEVER | Sep 21, 1981 | Substantially Equivalent | Proto-Med, Inc. |
FEI Numbers
This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.