Chrysalis Intelligence · Product Codes · FCX

FCX · Unclassified

5 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
5
2020-06-23 → 2026-07-24
Last 12 months
1
Unique sponsors
4
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Palliare , Ltd. 2 0 2023-03-24
VISION MEDICAL Co., Ltd. 1 1 2026-07-24
Ide Vision, Ltd. 1 0 2024-10-30
Karl Storz Endoscopy America, Inc. 1 0 2020-06-23
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
31624 CPT High Endoscopy with biopsy/procedures using insufflation is standard; FCX supplies CO2 for endoscopic procedures
C1751 HCPCS Catheter, infusion, inserted peripherally, centrally or midline (other than hemodialysis) ✓ CMS-verified description Medium Insufflation equipment may be billed as supply or component depending on context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K262152 VISION MEDICAL Co., Ltd. VS-370CF, VS-370CT
2024-10-30 K240847 Ide Vision, Ltd. MedicCO2LON (MedicCO2LON)
2023-03-24 K230474 Palliare , Ltd. EVA5 Insufflator
2021-07-08 K202922 Palliare , Ltd. END 200 Endoscopic Tubeset
2020-06-23 K201096 Karl Storz Endoscopy America, Inc. CO2mbiLED