Chrysalis Intelligence · Product Codes · KNF

KNF · Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Obstetrics/Gynecology · 7 clearances · 2 unique sponsors

Device class
Class II
Regulation 884.4160
Total clearances
7
2020-05-04 → 2026-09-24
Last 12 months
1
Unique sponsors
2
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.4160
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
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
Karl Storz SE & CO. KG 1 1 2026-09-24
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
2026-09-24 K254303 Karl Storz SE & CO. KG KARL STORZ SUPRALOOP
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