Atlas FDA

MEDLINE SURGICAL SPONGE SCANNER

FDA 510(k) clearance K061316 · decided 2006-11-02

Clearance details

K-number
K061316
Device name
MEDLINE SURGICAL SPONGE SCANNER
Applicant
Medline Industries, Inc.
Decision
Substantially Equivalent
Date received
2006-05-11
Decision date
2006-11-02
Days to decision
175 days
Clearance type
Traditional
Product code
LWH
Device class
1
Regulation number
880.2740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mundelein, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medline Industries

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 Solutions2009-12-18
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
SURGICOUNT SAFETY-SPONGE SYSTEM (K060076)Surgicount Medical2006-03-14
MARKWELL GAUZE SPONGE (K982260)Markwell Intl., Inc.1998-08-12
POCKET COUNT OR SAFETCOUNT (K972302)Sage Products, Inc.1997-07-25
SPONGE COUNT (K945144)Michael Fischer Assoc.1995-01-12
DEVON SPONGE COUNTER BAGS (K912824)Devon Industries, Inc.1991-08-26

Recalls involving this device

RecordFirmDate
Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotto recall (Z-2321-2008)Medline Industries Inc2008-09-20