Product Code: HHF FDA class 1 21 CFR 884.4530

Remover, Intrauterine Device, Contraceptive, Hook-Type

Obstetrics/Gynecology

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.

510(k)s
6
FEI Numbers
52
Registration Numbers
52
Unique Applicants
5
Years Active
12

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number Device Name
K926541 IUD HOOKS
K891030 IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR
K842295 INTRAUTERINE DEVICE REMOVER
K831568 RELIANCE TEMPO OPHTH. INSTR STAND
K820115 EMMETT IUD THREAD RETREIVER
K811761 THE EMMETT IUD THREAD RETRIEVER

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.