| 2026-08-10 |
K254069 |
Hemoclip (511 series, 543 series) |
PKL |
Class II |
Gastroenterology, Urology |
| 2026-06-24 |
K253393 |
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 |
FGE |
Class II |
Gastroenterology, Urology |
| 2026-04-08 |
K252270 |
Hemoclip |
PKL |
Class II |
Gastroenterology, Urology |
| 2025-11-12 |
K252271 |
Hemoclip |
PKL |
Class II |
Gastroenterology, Urology |
| 2025-03-20 |
K241704 |
Endoscopic Water Pump |
OCX |
— |
— |
| 2023-05-03 |
K222421 |
Sphincterotome |
KNS |
— |
— |
| 2023-03-03 |
K221713 |
Polypectomy Snare |
FDI |
Class II |
Gastroenterology, Urology |
| 2022-07-12 |
K213143 |
Hemoclip |
PKL |
Class II |
Gastroenterology, Urology |
| 2022-04-06 |
K213578 |
Balloon Dilatation Catheter |
FDF |
— |
— |
| 2022-03-03 |
K211787 |
Hemoclip |
PKL |
Class II |
Gastroenterology, Urology |
| 2021-10-05 |
K210406 |
Bipolar Coagulation Foreceps |
KGE |
Class II |
Gastroenterology, Urology |
| 2021-02-05 |
K201121 |
Sphincterotome |
KNS |
— |
— |
| 2020-12-23 |
K202237 |
Locking device |
ODC |
Class II |
Gastroenterology, Urology |
| 2020-12-16 |
K201509 |
Disposable Stone Extraction basket |
LQR |
Class II |
Gastroenterology, Urology |
| 2020-05-21 |
K192342 |
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) |
KNS |
— |
— |
| 2020-05-01 |
K200173 |
Stone Retrieval Balloon |
GCA |
— |
— |
| 2020-02-27 |
K190032 |
Disposable Sclerotherapy Needle |
FBK |
Class II |
Gastroenterology, Urology |