Counter, Sponge, Surgical
The Surgical Sponge Counter (product code LWH) is a device used during surgical procedures to track and count sponges and other surgical materials to prevent inadvertent retention of foreign objects in the patient. Regulated under 21 CFR 880.2740 and classified as a Class 1 device subject only to general controls, it is reviewed under the General Hospital panel within the General Hospital specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LWH
- Device Class
- FDA class 1
- Regulation Number
- 880.2740
- Medical Specialty
- General Hospital
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121274 | PIXEL APP | Jun 27, 2012 | Substantially Equivalent | Gauss Surgical, Inc., |
| K120473 | PIXEL APP | Apr 09, 2012 | Substantially Equivalent | Gauss Surgical, Inc., |
| K100551 | ORLOCATE SYSTEM MODEL ORL 100 | Aug 12, 2010 | Substantially Equivalent | Haldor Advanced Technologies, Ltd. |
| K093557 | SMARTWAND-DTX | Dec 18, 2009 | Substantially Equivalent | Clearcount Medical Solutions |
| K073180 | SMARTSPONGE PLUS SYSTEM | Nov 19, 2007 | Substantially Equivalent | Clearcount Medical Solutions, Inc. |
| K071355 | SMARTSPONGE SYSTEM | May 24, 2007 | Substantially Equivalent | Clearcount Medical Solutions, Inc. |
| K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | Nov 02, 2006 | Substantially Equivalent | Rf Surgical Systems, Inc. |
| K061316 | MEDLINE SURGICAL SPONGE SCANNER | Nov 02, 2006 | Substantially Equivalent | Medline Industries, Inc. |
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM | Mar 14, 2006 | Substantially Equivalent | Surgicount Medical |
| K982260 | MARKWELL GAUZE SPONGE | Aug 12, 1998 | Substantially Equivalent | Markwell Intl., Inc. |
| K972302 | POCKET COUNT OR SAFETCOUNT | Jul 25, 1997 | Substantially Equivalent | Sage Products, Inc. |
| K945144 | SPONGE COUNT | Jan 12, 1995 | Substantially Equivalent | Michael Fischer Assoc. |
| K912824 | DEVON SPONGE COUNTER BAGS | Aug 26, 1991 | Substantially Equivalent | Devon Industries, Inc. |
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Oct 23, 1987 | Substantially Equivalent | Gorsk, Inc. |
| K790538 | SPONGE COUNTER | Apr 04, 1979 | Substantially Equivalent | Devon Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.