Chrysalis Intelligence · Product Codes · FAS

FAS · Unclassified

6 clearances · 6 unique sponsors

Device class
Regulation —
Total clearances
6
2021-05-19 → 2025-12-05
Last 12 months
1
Unique sponsors
6
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
Multi4 Medical AB 1 0 2025-06-27
Chirurgie Innovation 1 0 2022-03-02
Lamidey Noury Medical 1 0 2024-06-12
Olympus Winter & Ibe GmbH 1 0 2021-08-03
Dornier Medtech America Inc (Dmta) 1 1 2025-12-05
Dornier Medtech America, Inc. 1 0 2021-05-19
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
52354 CPT Medium CPT code for cystourethroscopy with electrosurgical fulguration
A4706 HCPCS Bicarbonate concentrate, solution, for hemodialysis, per gallon ✓ CMS-verified description Medium HCPCS code for electrosurgical electrode, each
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-12-05 K251403 Dornier Medtech America Inc (Dmta) Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
2025-06-27 K250522 Multi4 Medical AB Multi4 System
2024-06-12 K240504 Lamidey Noury Medical PLASMA EDGE System
2022-03-02 K213135 Chirurgie Innovation Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
2021-08-03 K210651 Olympus Winter & Ibe GmbH Resection Electrodes with HF cable
2021-05-19 K210394 Dornier Medtech America, Inc. Electrosurgical accessory