| 2026-04-24 |
K252492 |
Visualized Access and Delivery Catheter; PB Digital Controller |
SHU |
— |
— |
| 2026-02-21 |
K251692 |
Advanced Tissue Resection Device |
FDI |
Class II |
Gastroenterology, Urology |
| 2025-09-08 |
K250229 |
Dual Action Tissue Closure Device |
PKL |
Class II |
Gastroenterology, Urology |
| 2025-06-27 |
K243388 |
Disposable Distal Cap |
FDS |
— |
— |
| 2024-12-16 |
K243471 |
Extraction Basket |
LQR |
Class II |
Gastroenterology, Urology |
| 2023-09-06 |
K230127 |
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 |
FGE |
Class II |
Gastroenterology, Urology |
| 2023-02-16 |
K221784 |
Single-use Video Pancreaticobiliary Scope, PB Digital Controller |
FBN |
Class II |
Gastroenterology, Urology |
| 2022-10-03 |
K222354 |
Elastic Traction System |
QSW |
Class II |
Gastroenterology, Urology |
| 2022-07-20 |
K213060 |
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle |
KTI |
Class II |
Ear, Nose, Throat |
| 2022-07-08 |
K220424 |
Through the Scope Tracheal Stent System |
JCT |
Class II |
General, Plastic Surgery |
| 2022-06-13 |
K220157 |
Disposable Hemostatic Closure Clip Device |
PKL |
Class II |
Gastroenterology, Urology |
| 2022-05-06 |
K211021 |
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible |
FGE |
Class II |
Gastroenterology, Urology |
| 2022-03-29 |
K220247 |
Guidewire Locking Device |
ODC |
Class II |
Gastroenterology, Urology |
| 2022-01-20 |
K212748 |
Disposable Dual Action Tissue Clip |
PKL |
Class II |
Gastroenterology, Urology |
| 2021-12-17 |
K211172 |
Single Use Electrosurgical Knife with Fluid Pump System |
GEI |
Class II |
General, Plastic Surgery |
| 2021-12-06 |
K212852 |
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle |
ODG |
Class II |
Gastroenterology, Urology |
| 2021-12-01 |
K210934 |
Sphincterotome / short-wire compatible, Sterile Sphincterotome |
KNS |
— |
— |
| 2021-10-30 |
K212403 |
Tracheal Stent System (Y-Shaped) |
JCT |
Class II |
General, Plastic Surgery |
| 2021-09-01 |
K202204 |
Tracheal Stent System |
JCT |
Class II |
General, Plastic Surgery |
| 2021-03-15 |
K202438 |
Ensure Single-Use Coagulation Forceps |
KGE |
Class II |
Gastroenterology, Urology |
| 2021-01-14 |
K202333 |
Lockado Repositionable Hemostasis Clip |
PKL |
Class II |
Gastroenterology, Urology |
| 2020-11-03 |
K200071 |
Blue Beacon Submucosal Injectable Solution |
PLL |
Class II |
Gastroenterology, Urology |
| 2020-07-24 |
K193601 |
Single Use Electrosurgical Knife |
GEI |
Class II |
General, Plastic Surgery |