Chrysalis Intelligence · Product Codes · KNF

KNF · Unclassified

6 clearances · 1 unique sponsors

Device class
Regulation —
Total clearances
6
2020-05-04 → 2025-04-02
Last 12 months
0
Unique sponsors
1
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
Gynesonics, Inc. 6 0 2025-04-02
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
58674 CPT High Standard CPT for hysteroscopic procedures with electrosurgical coagulation-cutting devices
49320 CPT Medium CPT for laparoscopic procedures with unipolar electrosurgical instruments
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-02 K250705 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2
2024-07-17 K240503 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2
2023-12-21 K233848 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
2022-11-08 K222304 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2
2021-06-17 K211535 Gynesonics, Inc. Sonata Transcervical Fibroid Ablation System 2.2
2020-05-04 K193516 Gynesonics, Inc. Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1