FDA 510(k) Applications Submitted by Laura Reynolds
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110647 |
03/07/2011 |
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS |
SMITH & NEPHEW, INC. |
| K110958 |
04/05/2011 |
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH |
SMITH & NEPHEW, INC. |
| K151326 |
05/18/2015 |
RENASYS┐ EZ PLUS Negative Pressure Wound Therapy Device |
Smith & Nephew, Inc. |
| K102001 |
07/15/2010 |
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY |
SMITH & NEPHEW, INC. |
| K162129 |
08/01/2016 |
RENASYS-G Gauze Dressing Kits with Soft Port |
Smith & Nephew, Inc. |
| K152163 |
08/03/2015 |
RENASYS GO |
SMITH & NEPHEW, INC. |
| K132446 |
08/06/2013 |
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE |
SMITH & NEPHEW, INC. |
| K143115 |
10/30/2014 |
The VersaJet II Hydrosurgery System |
SMITH & NEPHEW, INC. |
| K143133 |
10/31/2014 |
RENASYS┐ EZ MAX Negative Pressure Wound Therapy Device, RENASYS┐ AB Abdominal Dressing Kit with Soft Port Device |
SMITH & NEPHEW, INC. |
| K153209 |
11/05/2015 |
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply |
SMITH & NEPHEW MEDICAL LTD. |
| K100787 |
03/19/2010 |
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT |
SMITH & NEPHEW, INC. |
| K112784 |
09/26/2011 |
RENASYS AB ABOMINAL DRESSING KIT |
SMITH & NEPHEW, INC. |
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