FDA product code HTC: Pliers, Surgical
HTC is the FDA product code for pliers, surgical. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 10 510(k) submissions under HTC, from 2 different applicants. The average 510(k) review took 29 days (median 24). FDA has posted 4 recalls for HTC devices.
Classification
| Field | Value |
|---|---|
| Device name | Pliers, Surgical |
| 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 HTC clearance
Top HTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Tool, Inc. | 9 | 1987-07-02 |
| The Anspach Effort, Inc. | 1 | 1983-04-12 |
Most recent HTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872384 | Med-Tool, Inc. | SIDE CUTTING PARALLEL ACTION PLIERS | 1987-07-02 | 13 |
| K864019 | Med-Tool, Inc. | NEEDLE NOSE PLIERS | 1986-10-30 | 15 |
| K861953 | Med-Tool, Inc. | PARALLEL ACTION PLIERS | 1986-06-06 | 17 |
| K854390 | Med-Tool, Inc. | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS | 1985-11-19 | 19 |
| K844600 | Med-Tool, Inc. | SLIP JOINT PLIERS | 1984-12-14 | 17 |
Recalls for HTC devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2014-11-14.
Frequently asked questions
What is FDA product code HTC?
HTC is the FDA product code for pliers, surgical. 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 HTC?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTC?
Across 10 cleared submissions the average was 29 days from receipt to decision (median 24).
Which companies have the most HTC clearances?
Med-Tool, Inc. (9); The Anspach Effort, Inc. (1).
Have HTC devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2014-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code HTC
- Run a recall and safety report across every HTC manufacturer
- Watch product code HTC 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