Chrysalis Intelligence · Product Codes · GCA

GCA · Unclassified

6 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
6
2020-02-27 → 2026-05-08
Last 12 months
1
Unique sponsors
6
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Jiangsu Vedkang Medical Science and Technology Co., Ltd. 1 0 2024-02-26
Anrei Medical (Hangzhou) Co., Ltd. 1 0 2021-04-27
Hangzhou AGS MedTech Co., Ltd. 1 0 2020-05-01
Zhejiang Soudon Medical Technology Co., Ltd. 1 1 2026-05-08
Wilson-Cook Medical, Inc. 1 0 2020-02-27
Boston Scientific Corporation 1 0 2022-05-06
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
47544 CPT Medium CPT for endoscopic biliary sphincterotomy with stone removal; biliary catheter billed with ERCP procedure
99070 CPT Medium Biliary catheter device itself may be tracked as surgical supply
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-08 K253013 Zhejiang Soudon Medical Technology Co., Ltd. Disposable Stone Retrieval Balloon Catheter
2024-02-26 K232752 Jiangsu Vedkang Medical Science and Technology Co., Ltd. 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)
2022-05-06 K212582 Boston Scientific Corporation SpyGlass Discover Balloon Dilation Catheter
2021-04-27 K210660 Anrei Medical (Hangzhou) Co., Ltd. Stone Retrieval Balloon Catheter
2020-05-01 K200173 Hangzhou AGS MedTech Co., Ltd. Stone Retrieval Balloon
2020-02-27 K200247 Wilson-Cook Medical, Inc. Fusion Quattro Extraction Balloon