Chrysalis Intelligence · Product Codes · KOD

KOD · Catheter, Urological

Gastroenterology, Urology · 4 clearances · 4 unique sponsors

Device class
Class II
Regulation 876.5130
Total clearances
4
2021-11-19 → 2026-02-23
Last 12 months
1
Unique sponsors
4
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5130
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
Well Lead Medical Co., Ltd. 1 0 2022-12-16
Allwin Medical Devices, Inc. 1 0 2022-10-13
Urogen Pharma, Ltd. 1 0 2021-11-19
C.R. Bard, Inc. 1 1 2026-02-23
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
A4338 HCPCS Indwelling catheter; foley type, two-way latex with coating (teflon, silicone, silicone elastomer, or hydrophilic, etc.), each ✓ CMS-verified description High Indwelling catheter; Foley type, two or three way, latex
51701 CPT Medium Bladder catheterization; non-indwelling
51702 CPT Medium Bladder catheterization; indwelling
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-02-23 K251864 C.R. Bard, Inc. Rubber Utility Catheter
2022-12-16 K220036 Well Lead Medical Co., Ltd. Wellead Ureteral Catheter
2022-10-13 K220730 Allwin Medical Devices, Inc. allFlex Ureteral Catheters, Krait Ureteral Catheters
2021-11-19 K211032 Urogen Pharma, Ltd. Urinary Catheter 12 Fr, Urinary Catheter 16 Fr