FDA 510(k) Applications Submitted by JULIE POWELL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010166 |
01/18/2001 |
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
| K980617 |
01/23/1998 |
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER |
UROHEALTH SYSTEMS, INC. |
| K110563 |
02/28/2011 |
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP |
THERAPEUTICS 101, INC (DBA PRESSURE POINT, INC.) |
| K021174 |
04/12/2002 |
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR |
IMAGYN SURGICAL |
| K111326 |
05/11/2011 |
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM |
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. |
| K011575 |
05/22/2001 |
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 |
IMAGYN SURGICAL |
| K972328 |
06/23/1997 |
PERCUTANEOUS BREAST BIOPSY (PBB) |
UROTHEALTH SYSTEM, INC. |
| K972510 |
07/03/1997 |
PIVOTAL SCISSOR |
UROHEALTH SYSTEMS, INC. |
| K032491 |
08/12/2003 |
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
| K113265 |
11/04/2011 |
GENII GI 4000 ELECTROSUGICAL GENERATOR |
GENII, INC. |
| K993936 |
11/19/1999 |
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE |
IMAGYN SURGICAL |
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