Chrysalis Intelligence · Product Codes · EZN

EZN · Dilator, Catheter, Ureteral

Gastroenterology, Urology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 876.5470
Total clearances
3
2020-06-11 → 2025-05-22
Last 12 months
0
Unique sponsors
3
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5470
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Coloplast Corp. 1 0 2020-06-11
Allwin Medical Devices, Inc. 1 0 2023-05-05
Urotronic, Inc. 1 0 2025-05-22
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
52341 CPT Medium CPT code for cystourethroscopy with treatment of ureteral stricture
A4220 HCPCS Refill kit for implantable infusion pump ✓ CMS-verified description Medium HCPCS code for irrigating solution for urological irrigation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-22 K250910 Urotronic, Inc. Optilume® High Pressure Urological Balloon Dilation Catheter
2023-05-05 K220781 Allwin Medical Devices, Inc. ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
2020-06-11 K201007 Coloplast Corp. In-Ka Ureteral Balloon Dilatation Catheter