FDA 510(k) Applications Submitted by Sally He
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200071 |
01/13/2020 |
Blue Beacon Submucosal Injectable Solution |
Micro-Tech (Nanjing) Co., Ltd. |
| K230127 |
01/17/2023 |
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible |
Micro-Tech (Nanjing) Co., Ltd. |
| K220157 |
01/19/2022 |
Disposable Hemostatic Closure Clip Device |
Micro-Tech (Nanjing) Co., Ltd. |
| K220247 |
01/28/2022 |
Guidewire Locking Device |
Micro-Tech (Nanjing) Co., Ltd. |
| K220424 |
02/14/2022 |
Through the Scope Tracheal Stent System |
Micro-Tech (Nanjing) Co., Ltd. |
| K210934 |
03/29/2021 |
Sphincterotome / short-wire compatible, Sterile Sphincterotome |
Micro-Tech (Nanjing) Co., Ltd. |
| K211172 |
04/19/2021 |
Single Use Electrosurgical Knife with Fluid Pump System |
Micro-Tech (Nanjing) Co., Ltd. |
| K221784 |
06/21/2022 |
Single-use Video Pancreaticobiliary Scope, PB Digital Controller |
Micro-Tech (Nanjing) Co., Ltd |
| K212403 |
08/02/2021 |
Tracheal Stent System (Y-Shaped) |
Micro-Tech (Nanjing) Co., Ltd. |
| K222354 |
08/04/2022 |
Elastic Traction System |
Micro-Tech (Nanjing) Co., Ltd. |
| K202204 |
08/05/2020 |
Tracheal Stent System |
Micro-Tech (Nanjing) Co., Ltd. |
| K202333 |
08/17/2020 |
Lockado Repositionable Hemostasis Clip |
Micro-Tech (Nanjing) Co., Ltd. |
| K213060 |
09/22/2021 |
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle |
Micro-Tech (Nanjing) Co., Ltd. |
| K213782 |
12/03/2021 |
Single-Use Video Bronchoscopes, Digital Controller |
Micro-Tech (Nanjing) Co., Lts |
| K193601 |
12/23/2019 |
Single Use Electrosurgical Knife |
Micro-Tech (Nanjing) Co., Ltd. |
| K131588 |
05/31/2013 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
| K131892 |
06/25/2013 |
EV1000 CLINICAL PLATFORM |
EDWARDS LIFESCIENCES, LLC. |
| K965156 |
12/23/1996 |
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K992221 |
07/01/1999 |
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING |
WESTAIM BIOMEDICAL, INC. |
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