SPONGE COUNT
FDA 510(k) clearance K945144 · decided 1995-01-12
Clearance details
- K-number
- K945144
- Device name
- SPONGE COUNT
- Applicant
- Michael Fischer Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-20
- Decision date
- 1995-01-12
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LWH
- Device class
- 1
- Regulation number
- 880.2740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Winnetka, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PIXEL APP (K121274) | Gauss Surgical, Inc., | 2012-06-27 |
| PIXEL APP (K120473) | Gauss Surgical, Inc., | 2012-04-09 |
| ORLOCATE SYSTEM MODEL ORL 100 (K100551) | Haldor Advanced Technologies, Ltd. | 2010-08-12 |
| SMARTWAND-DTX (K093557) | Clearcount Medical Solutions | 2009-12-18 |
| SMARTSPONGE PLUS SYSTEM (K073180) | Clearcount Medical Solutions, Inc. | 2007-11-19 |
| SMARTSPONGE SYSTEM (K071355) | Clearcount Medical Solutions, Inc. | 2007-05-24 |
| RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (K062642) | Rf Surgical Systems, Inc. | 2006-11-02 |
| MEDLINE SURGICAL SPONGE SCANNER (K061316) | Medline Industries, Inc. | 2006-11-02 |
| SURGICOUNT SAFETY-SPONGE SYSTEM (K060076) | Surgicount Medical | 2006-03-14 |
| MARKWELL GAUZE SPONGE (K982260) | Markwell Intl., Inc. | 1998-08-12 |
| POCKET COUNT OR SAFETCOUNT (K972302) | Sage Products, Inc. | 1997-07-25 |
| DEVON SPONGE COUNTER BAGS (K912824) | Devon Industries, Inc. | 1991-08-26 |
Recalls involving this device
No recalls on record reference this clearance.