FDA 510(k) Applications Submitted by MICHAEL KOLBER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110127 |
01/18/2011 |
PRELUDE III TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
| K090530 |
02/27/2009 |
SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 |
ROSS CREEK MEDICAL INC. |
| K220901 |
03/28/2022 |
S-Core Implant System |
Subchondral Solutions, Inc. |
| K101060 |
04/15/2010 |
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
| K111179 |
04/27/2011 |
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN |
SIESTA MEDICAL, INC. |
| K201238 |
05/07/2020 |
Encore System |
Siesta Medical, Inc. |
| K121440 |
05/15/2012 |
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT |
SIESTA MEDICAL, INC. |
| K121814 |
06/20/2012 |
ENCORE TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
| K002054 |
07/06/2000 |
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 |
APPRIVA MEDICAL, INC. |
| K122336 |
08/02/2012 |
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM |
ELEVEN BLADE SOLUTIONS, INC. |
| K012489 |
08/03/2001 |
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 |
APPRIVA MEDICAL, INC. |
| K122954 |
09/25/2012 |
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 |
FOUNDRY NEWCO XI, INC. |
| K213159 |
09/28/2021 |
Encore System |
Siesta Medical, Inc. |
| K103179 |
10/28/2010 |
PRELUDE II TOUNGE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
| K183310 |
11/29/2018 |
Encore System |
Siesta Medical, Inc |
| K133680 |
12/02/2013 |
ENCORE SYSTEM |
SIESTA MEDICAL, INC. |
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