Chrysalis Intelligence · Product Codes · FFX

FFX · System, Gastrointestinal Motility (Electrical)

Gastroenterology, Urology · 6 clearances · 5 unique sponsors

Device class
Class II
Regulation 876.1725
Total clearances
6
2020-05-21 → 2025-12-05
Last 12 months
1
Unique sponsors
5
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
Covidien, LLC 2 0 2023-07-21
Anx Robotica Corp 1 0 2020-05-21
Laborie Medical Technologies, Corp. 1 0 2024-05-06
Medspira, LLC 1 1 2025-12-05
Medifactia AB 1 0 2023-01-18
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
91020 CPT — High Esophageal motility (manometric) study
91022 CPT — High Duodenal motility (manometric) study for GI motility assessment
C1764 HCPCS Event recorder, cardiac (implantable) ✓ CMS-verified description Medium GI motility monitoring system component
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-05 K252605 Medspira, LLC mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
2024-05-06 K240007 Laborie Medical Technologies, Corp. Solar Compact (G4-1)
2023-07-21 K231861 Covidien, LLC EndoflipTM 300 System
2023-04-14 K223705 Covidien, LLC EndoflipTM 300
2023-01-18 K222000 Medifactia AB Transit-Pellets
2020-05-21 K201106 Anx Robotica Corp IntraMarX 3D Radiopaque Marker