FDA 510(k) Applications Submitted by ELSA ABRUZZO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180152 |
01/19/2018 |
gel-e Flex |
gel-e, Inc. |
| K050459 |
02/23/2005 |
ATRICURE ISOLATOR TRANSPOLAR PEN |
ATRICURE, INC. |
| K192667 |
09/25/2019 |
gel-e Flex+ gel OTC |
gel-e, Inc. |
| K182811 |
10/03/2018 |
gel-e Flex+ |
gel-e, Inc. |
| K142944 |
10/10/2014 |
ArthroPlan Digital Templating Software |
Arthromeda, Inc |
| K061593 |
06/08/2006 |
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 |
ATRICURE, INC. |
| K063630 |
12/06/2006 |
ATRICURE ABLATION SYSTEM |
ATRICURE, INC. |
| K043579 |
12/28/2004 |
ATRICURE BIPOLAR SYSTEM |
ATRICURE, INC. |
| K221918 |
07/01/2022 |
ReFlow System Mini |
Anuncia Medical, Inc. |
| K052893 |
10/14/2005 |
ATRICURE TRANSPOLAR SYSTEM |
ATRICURE, INC. |
| K150660 |
03/13/2015 |
Alcyone MEMS Cannula (AMC) System |
ALCYONE LIFESCIENCES, INC. |
| K223603 |
12/02/2022 |
Reflow System Mini and ReFlow Mini Flusher |
Anuncia Medical, Inc. |
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