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Hangzhou AGS MedTech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories11
Latest FDA decision2026-08-10
TypeNumberDevice NameCodeDateActions
510(k) K254069 Hemoclip (511 series, 543 series)PKL2026-08-10 View
510(k) 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-5251-128019FGE2026-06-24 View
510(k) K252270 HemoclipPKL2026-04-08 View
510(k) K252271 HemoclipPKL2025-11-12 View
510(k) K241704 Endoscopic Water PumpOCX2025-03-20 View
510(k) K222421 SphincterotomeKNS2023-05-03 View
510(k) K221713 Polypectomy SnareFDI2023-03-03 View
510(k) K213143 HemoclipPKL2022-07-12 View
510(k) K213578 Balloon Dilatation CatheterFDF2022-04-06 View
510(k) K211787 HemoclipPKL2022-03-03 View
510(k) K210406 Bipolar Coagulation ForecepsKGE2021-10-05 View
510(k) K201121 SphincterotomeKNS2021-02-05 View
510(k) K202237 Locking deviceODC2020-12-23 View
510(k) K201509 Disposable Stone Extraction basketLQR2020-12-16 View
510(k) K192342 Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)KNS2020-05-21 View
510(k) K200173 Stone Retrieval BalloonGCA2020-05-01 View
510(k) K190032 Disposable Sclerotherapy NeedleFBK2020-02-27 View
510(k) K172729 Polypectomy SnareFDI2018-05-21 View
510(k) K172727 HemoclipPKL2018-04-16 View
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