FDA product code HCF: Instrument, Ligature Passing And Knot Tying
HCF is the FDA product code for instrument, ligature passing and knot tying. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under HCF, from 5 different applicants. The average 510(k) review took 82 days (median 75). FDA has posted 5 recalls for HCF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Ligature Passing And Knot Tying |
| 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 HCF clearance
Top HCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edwards Lifesciences, LLC | 1 | 2015-06-16 |
| Boston Scientific Corp | 1 | 1993-07-13 |
| Davis & Geck, Inc. | 1 | 1985-06-12 |
| Plastafil, Inc. | 1 | 1984-08-27 |
| J. Sklar Mfg. Co., Inc. | 1 | 1979-04-23 |
Most recent HCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150882 | Edwards Lifesciences, LLC | Edwards Suture Fastening System | 2015-06-16 | 75 |
| K931379 | Boston Scientific Corp | MICROVASIVE INSURG LAPTIE SUTURE LIGATOR | 1993-07-13 | 117 |
| K851452 | Davis & Geck, Inc. | VALTRAC PURSESTING DEVICE | 1985-06-12 | 62 |
| K841617 | Plastafil, Inc. | STROVER HOOK | 1984-08-27 | 130 |
| K790577 | J. Sklar Mfg. Co., Inc. | HEMORRHOIDAL LIGATOR | 1979-04-23 | 26 |
Recalls for HCF devices
5 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-29.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code HCF?
HCF is the FDA product code for instrument, ligature passing and knot tying. 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 HCF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HCF?
Across 5 cleared submissions the average was 82 days from receipt to decision (median 75).
Which companies have the most HCF clearances?
Edwards Lifesciences, LLC (1); Boston Scientific Corp (1); Davis & Geck, Inc. (1); Plastafil, Inc. (1); J. Sklar Mfg. Co., Inc. (1).
Have HCF devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2023-12-29.
Next steps
- Run an FDA pathway report with predicate devices for product code HCF
- Run a recall and safety report across every HCF manufacturer
- Watch product code HCF 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times