Chrysalis Intelligence · Product Codes · KLA

KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube

Gastroenterology, Urology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 876.1725
Total clearances
3
2024-04-23 → 2025-02-12
Last 12 months
0
Unique sponsors
3
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.1725
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
Neuraxis, Inc. 1 0 2024-12-06
Gi Bionics, LLC 1 0 2025-02-12
Laborie Medical Technologies, Corp. 1 0 2024-04-23
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
91010 CPT — High Standard CPT for esophageal motility (manometry) study
91122 CPT — High Standard CPT for anorectal manometry with line tracing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-02-12 K242666 Gi Bionics, LLC Fecobionics Anorectal System
2024-12-06 K242304 Neuraxis, Inc. RED
2024-04-23 K234107 Laborie Medical Technologies, Corp. Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)