FDA product code HTF: Curette
HTF is the FDA product code for curette. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under HTF, from 3 different applicants. The average 510(k) review took 19 days (median 11). FDA has posted 2 recalls for HTF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Curette |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTF clearance
Top HTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 1 | 1989-01-27 |
| Buckman Co., Inc. | 1 | 1987-03-09 |
| Stainless Mfg., Inc. | 1 | 1984-06-19 |
Most recent HTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890252 | Kinetic Medical Products | BONE CURETTE | 1989-01-27 | 9 |
| K870778 | Buckman Co., Inc. | ACROMED WALLIE-HEINIG CURETTES | 1987-03-09 | 11 |
| K841979 | Stainless Mfg., Inc. | 4MM CUP CURRETTE | 1984-06-19 | 36 |
Recalls for HTF devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-11-12.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code HTF?
HTF is the FDA product code for curette. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HTF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTF?
Across 3 cleared submissions the average was 19 days from receipt to decision (median 11).
Which companies have the most HTF clearances?
Kinetic Medical Products (1); Buckman Co., Inc. (1); Stainless Mfg., Inc. (1).
Have HTF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-11-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HTF
- Run a recall and safety report across every HTF manufacturer
- Watch product code HTF 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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