LWH · Counter, Sponge, Surgical
General Hospital · 21 CFR 880.2740 · Class 1
Overview
| Product Code | LWH |
|---|---|
| Device Name | Counter, Sponge, Surgical |
| Regulation | 21 CFR 880.2740 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121274 | PIXEL APP | Gauss Surgical, Inc., | Jun 27, 2012 | SESE |
| K120473 | PIXEL APP | Gauss Surgical, Inc., | Apr 9, 2012 | SESE |
| K100551 | ORLOCATE SYSTEM MODEL ORL 100 | Haldor Advanced Technologies, Ltd. | Aug 12, 2010 | SESE |
| K093557 | SMARTWAND-DTX | Clearcount Medical Solutions | Dec 18, 2009 | SESE |
| K073180 | SMARTSPONGE PLUS SYSTEM | Clearcount Medical Solutions, Inc. | Nov 19, 2007 | SESE |
| K071355 | SMARTSPONGE SYSTEM | Clearcount Medical Solutions, Inc. | May 24, 2007 | SESE |
| K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | Rf Surgical Systems, Inc. | Nov 2, 2006 | SESE |
| K061316 | MEDLINE SURGICAL SPONGE SCANNER | Medline Industries, Inc. | Nov 2, 2006 | SESE |
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM | Surgicount Medical | Mar 14, 2006 | SESE |
| K982260 | MARKWELL GAUZE SPONGE | Markwell Intl., Inc. | Aug 12, 1998 | SESE |
| K972302 | POCKET COUNT OR SAFETCOUNT | Sage Products, Inc. | Jul 25, 1997 | SESE |
| K945144 | SPONGE COUNT | Michael Fischer Assoc. | Jan 12, 1995 | SESE |
| K912824 | DEVON SPONGE COUNTER BAGS | Devon Industries, Inc. | Aug 26, 1991 | SESE |
| K873555 | GORSK SPONGE CONTAINMENT SYSTEM | Gorsk, Inc. | Oct 23, 1987 | SESE |
| K790538 | SPONGE COUNTER | Devon Industries, Inc. | Apr 4, 1979 | SESE |
Top Applicants
- Clearcount Medical Solutions, Inc. — 2 clearances
- Devon Industries, Inc. — 2 clearances
- Gauss Surgical, Inc., — 2 clearances
- Clearcount Medical Solutions — 1 clearance
- Gorsk, Inc. — 1 clearance
