FDA product code LWG: Surgical Table Cushion
LWG is the FDA product code for surgical table cushion. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under LWG, from 3 different applicants. The average 510(k) review took 30 days (median 26). FDA has posted 1 recall for LWG devices.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Table Cushion |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| 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 LWG clearance
Top LWG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Avec Scientific Design Corp. | 2 | 1988-08-23 |
| Karlin Technology, Inc. | 1 | 1988-07-18 |
| Cedar Surgical, Inc. | 1 | 1987-10-26 |
Most recent LWG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883295 | Avec Scientific Design Corp. | CHOP SPINE FRAME | 1988-08-23 | 19 |
| K882520 | Karlin Technology, Inc. | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | 1988-07-18 | 31 |
| K874494 | Avec Scientific Design Corp. | KAMBIN LAMINECTOMY FRAME | 1987-11-23 | 21 |
| K873690 | Cedar Surgical, Inc. | CEDAR(TM) PELVIC CUSHION | 1987-10-26 | 48 |
Recalls for LWG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-19.
Frequently asked questions
What is FDA product code LWG?
LWG is the FDA product code for surgical table cushion. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is LWG?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LWG?
Across 4 cleared submissions the average was 30 days from receipt to decision (median 26).
Which companies have the most LWG clearances?
Avec Scientific Design Corp. (2); Karlin Technology, Inc. (1); Cedar Surgical, Inc. (1).
Have LWG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-04-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LWG
- Run a recall and safety report across every LWG manufacturer
- Watch product code LWG 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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