Chrysalis Intelligence · Product Codes · OWT

OWT · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2020-03-26 → 2025-02-19
Last 12 months
0
Unique sponsors
3
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
Sofradim Production 1 0 2024-02-13
Davol, Inc., A Subsidiary of C.R. Bard, Inc. 1 0 2025-02-19
Novus Scientific AB 1 0 2020-03-26
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
49560 CPT High Repair initial inguinal hernia; open (includes umbilical hernia)
49561 CPT High Repair recurrent inguinal hernia; open
49565 CPT Medium Repair initial ventral/incisional hernia; open (includes umbilical hernia)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-02-19 K243241 Davol, Inc., A Subsidiary of C.R. Bard, Inc. Phasix ST Umbilical Hernia Patch
2024-02-13 K233661 Sofradim Production Transorb™ Self-Gripping Resorbable Mesh
2020-03-26 K191749 Novus Scientific AB TIGR Matrix Surgical Mesh, TIGR Surgical Mesh