LWH · Class I · 21 CFR 880.2740

FDA Product Code LWH: Counter, Sponge, Surgical

Leading manufacturers include Clearcount Medical Solutions, Inc., Gauss Surgical, Inc., and Devon Industries, Inc..

15
Total
15
Cleared
61d
Avg days
1979
Since

FDA 510(k) Cleared Counter, Sponge, Surgical Devices (Product Code LWH)

15 devices
1–15 of 15
Cleared Jun 27, 2012
PIXEL APP
K121274
Gauss Surgical, Inc.,
General & Plastic Surgery · 61d
Cleared Apr 09, 2012
PIXEL APP
K120473
Gauss Surgical, Inc.,
General & Plastic Surgery · 53d
Cleared Aug 12, 2010
ORLOCATE SYSTEM MODEL ORL 100
K100551
Haldor Advanced Technologies, Ltd.
General & Plastic Surgery · 167d
Cleared Dec 18, 2009
SMARTWAND-DTX
K093557
Clearcount Medical Solutions
General & Plastic Surgery · 32d
Cleared Nov 19, 2007
SMARTSPONGE PLUS SYSTEM
K073180
Clearcount Medical Solutions, Inc.
General & Plastic Surgery · 6d
Cleared May 24, 2007
SMARTSPONGE SYSTEM
K071355
Clearcount Medical Solutions, Inc.
General & Plastic Surgery · 9d
Cleared Nov 02, 2006
MEDLINE SURGICAL SPONGE SCANNER
K061316
Medline Industries, Inc.
General & Plastic Surgery · 175d
Cleared Nov 02, 2006
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
K062642
Rf Surgical Systems, Inc.
General & Plastic Surgery · 57d
Cleared Mar 14, 2006
SURGICOUNT SAFETY-SPONGE SYSTEM
K060076
Surgicount Medical
General & Plastic Surgery · 63d
Cleared Aug 12, 1998
MARKWELL GAUZE SPONGE
K982260
Markwell Intl., Inc.
General & Plastic Surgery · 47d
Cleared Jul 25, 1997
POCKET COUNT OR SAFETCOUNT
K972302
Sage Products, Inc.
General & Plastic Surgery · 36d
Cleared Aug 26, 1991
DEVON SPONGE COUNTER BAGS
K912824
Devon Industries, Inc.
General & Plastic Surgery · 61d
Cleared Apr 04, 1979
SPONGE COUNTER
K790538
Devon Industries, Inc.
General & Plastic Surgery · 15d

About Product Code LWH - Regulatory Context