FDA product code HHF: Remover, Intrauterine Device, Contraceptive, Hook-Type
HHF is the FDA product code for remover, intrauterine device, contraceptive, hook-type. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under HHF, from 5 different applicants. The average 510(k) review took 119 days (median 68). FDA has posted 1 recall for HHF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Remover, Intrauterine Device, Contraceptive, Hook-Type |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HHF clearance
Top HHF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Proto-Med, Inc. | 2 | 1982-02-05 |
| Thomasville Medical Assoc. | 1 | 1994-02-24 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-03-17 |
| Premier Dental Products Co. | 1 | 1984-10-12 |
| F. & F. Koenigkramer | 1 | 1983-06-30 |
Most recent HHF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926541 | Thomasville Medical Assoc. | IUD HOOKS | 1994-02-24 | 421 |
| K891030 | Zinnanti Surgical Instruments, Inc. | IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR | 1989-03-17 | 17 |
| K842295 | Premier Dental Products Co. | INTRAUTERINE DEVICE REMOVER | 1984-10-12 | 123 |
| K831568 | F. & F. Koenigkramer | RELIANCE TEMPO OPHTH. INSTR STAND | 1983-06-30 | 45 |
| K820115 | Proto-Med, Inc. | EMMETT IUD THREAD RETREIVER | 1982-02-05 | 18 |
Recalls for HHF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HHF?
HHF is the FDA product code for remover, intrauterine device, contraceptive, hook-type. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHF?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHF?
Across 6 cleared submissions the average was 119 days from receipt to decision (median 68).
Which companies have the most HHF clearances?
Proto-Med, Inc. (2); Thomasville Medical Assoc. (1); Zinnanti Surgical Instruments, Inc. (1); Premier Dental Products Co. (1); F. & F. Koenigkramer (1).
Have HHF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HHF
- Run a recall and safety report across every HHF manufacturer
- Watch product code HHF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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