Stone Retrieval Balloon— 510(k) K200173
Substantially EquivalentHangzhou AGS MedTech Co., Ltd.
FDA 510(k) clearance K200173 for Stone Retrieval Balloon, Substantially Equivalent on 2020-05-01. Applicant: Hangzhou AGS MedTech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou AGS MedTech Co., Ltd.
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code GCA
view all- K253013 — Disposable Stone Retrieval Balloon Catheter
- K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- K212582 — SpyGlass Discover Balloon Dilation Catheter
- K210660 — Stone Retrieval Balloon Catheter
- K200247 — Fusion Quattro Extraction Balloon
More clearances from Hangzhou AGS MedTech Co., Ltd.
view all- K254069 — Hemoclip (511 series, 543 series)
- 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
- K252270 — Hemoclip
- K252271 — Hemoclip
- K241704 — Endoscopic Water Pump
Data sourced from openFDA. This site is unofficial and independent of the FDA.