FDA 510(k) Applications Submitted by Gurvinder Singh Nanda
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110636 |
03/04/2011 |
TULA IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
| K251127 |
04/11/2025 |
PENTAX Medical Video Processor (EPK-i8020c) |
Pentax of America, Inc |
| K242110 |
07/19/2024 |
PENTAX Medical Video Colonoscope (EC38-i20cWL) |
Pentax of America, Inc. |
| K103595 |
12/08/2010 |
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM |
ACCLARENT, INC. |
| K012960 |
09/04/2001 |
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR |
BIOGENEX LABORATORIES |
| K013148 |
09/20/2001 |
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) |
BIOGENEX LABORATORIES |
| K240457 |
02/16/2024 |
C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) |
PENTAX of America, Inc. |
| K241213 |
04/30/2024 |
PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) |
Pentax of America, Inc |
| K233942 |
12/14/2023 |
PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) |
Pentax of America, Inc. |
| K190194 |
02/04/2019 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX Medical, A Division of PENTAX of America, Inc. |
| K203024 |
10/02/2020 |
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge |
PENTAX of America, Inc. |
| K193036 |
10/31/2019 |
C2 CryoBalloon EndoGrip |
PENTAX Medical, A Division of PENTAX of America, Inc. |
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