FDA product code LWH: Counter, Sponge, Surgical
LWH is the FDA product code for counter, sponge, surgical. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under LWH, from 12 different applicants. The average 510(k) review took 61 days (median 56). FDA has posted 4 recalls for LWH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Counter, Sponge, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 880.2740 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LWH clearance
Top LWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gauss Surgical, Inc., | 2 | 2012-06-27 |
| Clearcount Medical Solutions, Inc. | 2 | 2007-11-19 |
| Devon Industries, Inc. | 2 | 1991-08-26 |
| Haldor Advanced Technologies, Ltd. | 1 | 2010-08-12 |
| Clearcount Medical Solutions | 1 | 2009-12-18 |
7 more applicants have LWH clearances. See the full list in Caduvo.
Most recent LWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121274 | Gauss Surgical, Inc., | PIXEL APP | 2012-06-27 | 61 |
| K120473 | Gauss Surgical, Inc., | PIXEL APP | 2012-04-09 | 53 |
| K100551 | Haldor Advanced Technologies, Ltd. | ORLOCATE SYSTEM MODEL ORL 100 | 2010-08-12 | 167 |
| K093557 | Clearcount Medical Solutions | SMARTWAND-DTX | 2009-12-18 | 32 |
| K073180 | Clearcount Medical Solutions, Inc. | SMARTSPONGE PLUS SYSTEM | 2007-11-19 | 6 |
Recalls for LWH devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2026-03-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LWH?
LWH is the FDA product code for counter, sponge, surgical. It is a Class I device, regulated under 21 CFR 880.2740 and reviewed by the General and Plastic Surgery panel.
What device class is LWH?
Class I, regulation 21 CFR 880.2740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LWH?
Across 15 cleared submissions the average was 61 days from receipt to decision (median 56).
Which companies have the most LWH clearances?
Gauss Surgical, Inc., (2); Clearcount Medical Solutions, Inc. (2); Devon Industries, Inc. (2); Haldor Advanced Technologies, Ltd. (1); Clearcount Medical Solutions (1).
Have LWH devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2026-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code LWH
- Run a recall and safety report across every LWH manufacturer
- Watch product code LWH 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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