Chrysalis Intelligence · Product Codes · FCM

FCM · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Gastroenterology, Urology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 876.5130
Total clearances
3
2023-08-02 → 2026-05-29
Last 12 months
1
Unique sponsors
3
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
Coloplast 1 0 2023-08-02
Convatec Limited 1 0 2025-06-06
C.R. Bard, Inc. 1 1 2026-05-29
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 HCPCS code for indwelling urinary catheter kit with Foley catheter
A4344 HCPCS Indwelling catheter, foley type, two-way, all silicone or polyurethane, each ✓ CMS-verified description Medium HCPCS code for sterile external urethral catheter or intermittent straight catheterization kit
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-29 K254076 C.R. Bard, Inc. BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
2025-06-06 K250891 Convatec Limited Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
2023-08-02 K223821 Coloplast Self-Cath Closed System