FDA 510(k) Applications Submitted by THOMAS LAWSON, PHD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230005 |
01/03/2023 |
Pantheris LV Atherectomy Catheter |
Avinger, Inc. |
| K180214 |
01/25/2018 |
Repris Bladder Injection System |
URO-1, Inc. |
| K090485 |
02/25/2009 |
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 |
PERCUTANEOUS SYSTEMS, INCORPORATED |
| K220611 |
03/03/2022 |
SUREcore Plus Biopsy Instrument |
Uro-1, Inc. |
| K230594 |
03/03/2023 |
Tigereye ST CTO-Crossing Catheter |
Avinger, Inc. |
| K951620 |
04/07/1995 |
MIDMARK MIDLINE CATHETER |
MENLO CARE, INC. |
| K201330 |
05/19/2020 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
| K171500 |
05/23/2017 |
Uro-V Cystoscope |
UroViu Corporation |
| K201650 |
06/18/2020 |
VMCore Biopsy Needle |
URO-1, Inc. |
| K061766 |
06/22/2006 |
EXPRESSWAY INTERMITTENT CATHETER |
PERCUTANEOUS SYSTEMS, INCORPORATED |
| K212047 |
06/30/2021 |
Pantheris System |
Avinger, Inc. |
| K172236 |
07/25/2017 |
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled |
Avinger, Inc. |
| K052048 |
07/29/2005 |
ACCORDION |
PERCUTANEOUS SYSTEMS, INCORPORATED |
| K052134 |
08/05/2005 |
CYSTOGLIDE DILATING INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
| K212468 |
08/06/2021 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
| K052298 |
08/23/2005 |
CYSTOGLIDE INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INCORPORATED |
| K202445 |
08/26/2020 |
Hystero-V Hysteroscope |
Hysterovue, Inc. |
| K182341 |
08/28/2018 |
Pantheris SV |
Avinger, Inc. |
| K042531 |
09/17/2004 |
UPDATED SLIP UROLOGY INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INCORPORATED |
| K082803 |
09/24/2008 |
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 |
PERCUTANEOUS SYSTEMS, INC. |
| K182732 |
09/28/2018 |
JTL-250-01 |
Jointechlabs, Inc. |
| K202921 |
09/29/2020 |
Uro-G Cystoscope |
UroViu Corporation |
| K243196 |
10/01/2024 |
Uro-G HD Cystoscope (1520) |
UroViu Corporation |
| K182876 |
10/12/2018 |
Uro-N Cystoscope |
UroViu Corporation |
| K042877 |
10/18/2004 |
MICROVERTER URETERAL ACCESS SHEATH |
PERCUTANEOUS SYSTEMS, INC. |
| K173862 |
12/20/2017 |
Pantheris System |
Avinger, Inc. |
| K230646 |
03/08/2023 |
SUREcore Prime Biopsy Instrument |
Uro-1 Medical, Inc. |
| K102887 |
09/30/2010 |
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 |
PERCUTANEOUS SYSTEMS, INC. |
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