FDA product code LWK: Razor, Surgical
LWK is the FDA product code for razor, 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 4 510(k) submissions under LWK, from 3 different applicants. The average 510(k) review took 30 days (median 27). FDA has posted 6 recalls for LWK devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Razor, 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 LWK clearance
Top LWK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Derma-Safe Co. | 2 | 1987-11-13 |
| Wahl Clipper Corp. | 1 | 1995-01-24 |
| Baxter Healthcare Corp | 1 | 1991-03-28 |
Most recent LWK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946162 | Wahl Clipper Corp. | 3M(TM) SURGICAL SLIPPER, 9660 SERIES | 1995-01-24 | 36 |
| K910524 | Baxter Healthcare Corp | SURGICAL CLIPPER | 1991-03-28 | 49 |
| K874370 | Derma-Safe Co. | SURGICAL PREP RAZOR | 1987-11-13 | 18 |
| K874234 | Derma-Safe Co. | SURGICAL PREP RAZOR, STRAIGHT TYPE | 1987-11-02 | 18 |
Recalls for LWK devices
6 product recalls in 5 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2024-01-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code LWK?
LWK is the FDA product code for razor, 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 LWK?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LWK?
Across 4 cleared submissions the average was 30 days from receipt to decision (median 27).
Which companies have the most LWK clearances?
Derma-Safe Co. (2); Wahl Clipper Corp. (1); Baxter Healthcare Corp (1).
Have LWK devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-01-12.
Next steps
- Run an FDA pathway report with predicate devices for product code LWK
- Run a recall and safety report across every LWK manufacturer
- Watch product code LWK 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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