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
Medifactia AB 1 0 2023-01-18
Medspira, LLC 1 1 2025-12-05
Laborie Medical Technologies, Corp. 1 0 2024-05-06
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