FDA product code HAB: Saw, Powered, And Accessories
HAB is the FDA product code for saw, powered, and accessories. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under HAB, from 2 different applicants. The average 510(k) review took 100 days (median 100). FDA has posted 16 recalls for HAB devices.
Classification
| Field | Value |
|---|---|
| Device name | Saw, Powered, And Accessories |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| 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 HAB clearance
Top HAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Linvatec Corp. | 1 | 2001-10-19 |
| Surgiquip, Inc. | 1 | 1994-03-10 |
Most recent HAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012320 | Linvatec Corp. | POWERPRO BATTERY SYSTEM | 2001-10-19 | 88 |
| K935517 | Surgiquip, Inc. | SNAP STERNUM SAW | 1994-03-10 | 112 |
Recalls for HAB devices
16 product recalls in 7 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-08-27.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code HAB?
HAB is the FDA product code for saw, powered, and accessories. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is HAB?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HAB?
Across 2 cleared submissions the average was 100 days from receipt to decision (median 100).
Which companies have the most HAB clearances?
Linvatec Corp. (1); Surgiquip, Inc. (1).
Have HAB devices been recalled?
Yes: 16 product recalls across 7 recall events; the most recent began 2018-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HAB
- Run a recall and safety report across every HAB manufacturer
- Watch product code HAB 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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