FDA product code HFC: Aspirator, Endocervical
HFC is the FDA product code for aspirator, endocervical. It is a Class II device, regulated under 21 CFR 884.1050 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under HFC, from 10 different applicants. The average 510(k) review took 106 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Aspirator, Endocervical |
| Device class | Class II |
| Regulation | 21 CFR 884.1050 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HFC clearance
Top HFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Urological, Inc. | 2 | 1996-08-29 |
| A & A Medical, Inc. | 1 | 1997-12-22 |
| Select Medical Systems, Inc. | 1 | 1995-11-21 |
| Innovative Medical Products, Inc. | 1 | 1990-10-09 |
| Customed, Inc. | 1 | 1990-09-28 |
5 more applicants have HFC clearances. See the full list in Caduvo.
Most recent HFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974032 | A & A Medical, Inc. | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | 1997-12-22 | 60 |
| K960263 | Cook Urological, Inc. | CERVICAL MUCOUS ASPIRATION CATHETER | 1996-08-29 | 224 |
| K954903 | Cook Urological, Inc. | PEDI VAGINAL ASPIRATOR | 1996-04-29 | 187 |
| K954102 | Select Medical Systems, Inc. | SELECTMUCUS | 1995-11-21 | 82 |
| K902242 | Innovative Medical Products, Inc. | ENDOCERVICAL ASPIRATOR | 1990-10-09 | 144 |
Recalls for HFC devices
openFDA lists no recalls for product code HFC.
Frequently asked questions
What is FDA product code HFC?
HFC is the FDA product code for aspirator, endocervical. It is a Class II device, regulated under 21 CFR 884.1050 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFC?
Class II, regulation 21 CFR 884.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFC?
Across 11 cleared submissions the average was 106 days from receipt to decision (median 82).
Which companies have the most HFC clearances?
Cook Urological, Inc. (2); A & A Medical, Inc. (1); Select Medical Systems, Inc. (1); Innovative Medical Products, Inc. (1); Customed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFC
- Run a recall and safety report across every HFC manufacturer
- Watch product code HFC 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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