Chrysalis Intelligence · Product Codes · PCU

PCU · Unclassified

3 clearances · 2 unique sponsors

Device class
Regulation —
Total clearances
3
2021-04-15 → 2026-03-13
Last 12 months
1
Unique sponsors
2
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
Boston Scientific Corporation 2 0 2022-09-07
Taewoong Medical Co., Ltd. 1 1 2026-03-13
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
43270 CPT High Endoscopic pancreatic/ampullary sphincterotomy and stent placement for pseudocyst drainage
43275 CPT Medium Endoscopic sphincter pressure measurement; alternative pancreatic endoscopy code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-13 K252648 Taewoong Medical Co., Ltd. Niti-S SPAXUS Stent
2022-09-07 K220112 Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System
2021-04-15 K203132 Boston Scientific Corporation AXIOS Stent and Electrocautery Enhanced Delivery System