Chrysalis Intelligence · Product Codes · GBM

GBM · Catheter, Urethral

Gastroenterology, Urology · 9 clearances · 7 unique sponsors

Device class
Class II
Regulation 876.5130
Total clearances
9
2020-05-07 → 2025-03-05
Last 12 months
0
Unique sponsors
7
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 3 0 2020-11-13
Hangzhou Jimushi Meditech Co., Ltd. 1 0 2020-06-01
Hakki Medical Technologies, Inc. 1 0 2020-05-21
Well Lead Medical Co., Ltd. 1 0 2025-03-05
Convatec Limited 1 0 2022-06-22
B.Braun Medical, Inc. 1 0 2020-05-07
Hollister Incorporated 1 0 2022-01-27
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
51798 CPT Medium CPT for transurethral resection procedures; urethral catheter billing depends on procedure context
99070 CPT Medium Urethral catheter may be billed as surgical supply with diagnostic/therapeutic code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-03-05 K241734 Well Lead Medical Co., Ltd. Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
2022-06-22 K213283 Convatec Limited GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
2022-01-27 K211436 Hollister Incorporated Intermittent Catheter (Not Finalized)
2020-11-13 K200820 Coloplast SpeediCath Compact Set
2020-11-02 K192904 Coloplast SpeediCath Compact Set
2020-07-30 K200142 Coloplast SpeediCath Soft
2020-06-01 K200134 Hangzhou Jimushi Meditech Co., Ltd. Jimushi Sterile Urethral Catheter for single use
2020-05-21 K191512 Hakki Medical Technologies, Inc. LotusCatheter (Lotus No Balloon Catheter)
2020-05-07 K192577 B.Braun Medical, Inc. Actreen Hi-Lite Intermittent Urinary Catheters