FDA 510(k) Applications Submitted by BARBARA J WHITMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180248 |
01/29/2018 |
VascuEase IC-1200-WH |
Bio Compression Systems, Inc. |
| K191547 |
06/12/2019 |
ReliefBand |
ReliefBand Technologies LLC |
| K142640 |
09/17/2014 |
Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator |
BIO COMPRESSION SYSTEMS, INC. |
| K182960 |
10/25/2018 |
ReliefBand |
ReliefBand Technologies LLC |
| K063746 |
12/18/2006 |
POWER EXTENDERS MODEL# PEC200, PES200,PES200S |
POWER MEDICAL INTERVENTIONS, INC. |
| K040024 |
01/07/2004 |
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 |
POWER MEDICAL INTERVENTIONS, INC. |
| K040398 |
02/17/2004 |
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
| K020719 |
03/05/2002 |
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES |
POWER MEDICAL INTERVENTIONS, INC. |
| K040720 |
03/19/2004 |
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM |
POWER MEDICAL INTERVENTIONS, INC. |
| K150953 |
04/09/2015 |
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC |
BIO COMPRESSION SYSTEMS, INC. |
| K021249 |
04/19/2002 |
SURGASSIST FLEXSHAFT 2, MODEL FS2 14 |
POWER MEDICAL INTERVENTIONS, INC. |
| K091215 |
04/27/2009 |
INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT |
POWER MEDICAL INTERVENTIONS, INC. |
| K021701 |
05/23/2002 |
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 |
POWER MEDICAL INTERVENTIONS, INC. |
| K061649 |
06/13/2006 |
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH |
POWER MEDICAL INTERVENTIONS, INC. |
| K071708 |
06/21/2007 |
I45, I45S, I60, AND I60S |
POWER MEDICAL INTERVENTIONS, INC. |
| K081826 |
06/27/2008 |
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V |
POWER MEDICAL INTERVENTIONS, INC. |
| K022313 |
07/17/2002 |
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V |
POWER MEDICAL INTERVENTIONS, INC. |
| K032701 |
09/02/2003 |
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) |
POWER MEDICAL INTERVENTIONS, INC. |
| K052415 |
09/02/2005 |
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
| K063075 |
10/06/2006 |
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS |
POWER MEDICAL INTERVENTIONS, INC. |
| K052910 |
10/17/2005 |
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
| K073001 |
10/24/2007 |
IDRIVES, IDRIVEC, IDRIVEF |
POWER MEDICAL INTERVENTIONS, INC. |
| K073148 |
11/08/2007 |
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS |
POWER MEDICAL INTERVENTIONS, INC. |
| K083527 |
11/28/2008 |
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS |
POWER MEDICAL INTERVENTIONS, INC. |
| K171793 |
06/16/2017 |
Sequential Circulator SC-2004FC-OC |
Bio Compression Systems, Inc. |
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