FDA Product Code
FDA Product Code LWH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2740
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K121274 | PIXEL APP | Gauss Surgical, Inc., | 2012-06-27 | Special | PDF ↗ |
| K120473 | PIXEL APP | Gauss Surgical, Inc., | 2012-04-09 | Traditional | PDF ↗ |
| K100551 | ORLOCATE SYSTEM MODEL ORL 100 | Haldor Advanced Technologies, Ltd. | 2010-08-12 | Traditional | PDF ↗ |
| K093557 | SMARTWAND-DTX | Clearcount Medical Solutions | 2009-12-18 | Traditional | PDF ↗ |
| K073180 | SMARTSPONGE PLUS SYSTEM | Clearcount Medical Solutions, Inc. | 2007-11-19 | Traditional | PDF ↗ |
| K071355 | SMARTSPONGE SYSTEM | Clearcount Medical Solutions, Inc. | 2007-05-24 | Traditional | PDF ↗ |
| K061316 | MEDLINE SURGICAL SPONGE SCANNER | Medline Industries, Inc. | 2006-11-02 | Traditional | PDF ↗ |
| K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | Rf Surgical Systems, Inc. | 2006-11-02 | Traditional | PDF ↗ |
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM | Surgicount Medical | 2006-03-14 | Traditional | PDF ↗ |
| K982260 | MARKWELL GAUZE SPONGE | Markwell Intl., Inc. | 1998-08-12 | Traditional | PDF ↗ |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K945144 | SPONGE COUNT | Michael Fischer Assoc. | 1995-01-12 | Traditional | PDF ↗ |
| K912824 | DEVON SPONGE COUNTER BAGS | Devon Industries, Inc. | 1991-08-26 | Traditional | PDF ↗ |
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Gorsk, Inc. | 1987-10-23 | Traditional | PDF ↗ |
| K790538 | SPONGE COUNTER | Devon Industries, Inc. | 1979-04-04 | Traditional | PDF ↗ |
Product code LWH · Class I · General Hospital. Data: openFDA.