510(k) K093557
- Device
- SMARTWAND-DTX
- Applicant
- CLEARCOUNT MEDICAL SOLUTIONS
- 510(k) number
- K093557
- Product code
- LWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-18
- Date received
- 2009-11-16
- Regulation
- 880.2740
- Classification name
- Counter, Sponge, Surgical
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- JEFF WOLFGONG
- Address
- 101 Bellevue Rd., Suite 300 Pittsburgh PA US 15229 15229
FDA Registration Numbers#
- 3011120183
- 3032960221
- 3005841027
- 3009425497
- 1055236
- 3007407626
- 3004215117
- 3019315696
- 3015967359
- 3005160949
- 3013298431
- 1417592
- 1043572
- 3009659860
- 3005210579
- 2030732
- 3016761372
- 3007305426
- 3008879776
- 3010305275
- 3006487092
- 3009542933
- 3014421917
- 2029275
- 3007773213
- 3014257280
- 3032171543
- 1043214
- 1030451
- 3018094310
- 3023602990
- 3035642068
- 1423537
- 3015058854
- 3013443304
- 9614062
- 3012494290
- 3018781093
- 9611959
- 3014926389
- 3010453313
- 3017270814
- 3005524530
- 1054241
- 3006847952
- 8010177
- 3016734231
- 1921846
- 3017309443
- 3004496839
Source Documents#
Other 510(k) Records For Product Code LWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121274 | PIXEL APP | Gauss Surgical, Inc., | 2012-06-27 |
| K120473 | PIXEL APP | Gauss Surgical, Inc., | 2012-04-09 |
| K100551 | ORLOCATE SYSTEM MODEL ORL 100 | Haldor Advanced Technologies, Ltd. | 2010-08-12 |
| K073180 | SMARTSPONGE PLUS SYSTEM | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| K071355 | SMARTSPONGE SYSTEM | Clearcount Medical Solutions, Inc. | 2007-05-24 |
| K061316 | MEDLINE SURGICAL SPONGE SCANNER | Medline Industries, Inc. | 2006-11-02 |
| K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | Rf Surgical Systems, Inc. | 2006-11-02 |
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM | Surgicount Medical | 2006-03-14 |
| K982260 | MARKWELL GAUZE SPONGE | Markwell Intl., Inc. | 1998-08-12 |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | 1997-07-25 |
| K945144 | SPONGE COUNT | Michael Fischer Assoc. | 1995-01-12 |
| K912824 | DEVON SPONGE COUNTER BAGS | Devon Industries, Inc. | 1991-08-26 |
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Gorsk, Inc. | 1987-10-23 |
| K790538 | SPONGE COUNTER | Devon Industries, Inc. | 1979-04-04 |
Legacy Summary#
summary
FDA Review#
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