KNF · Class II · 21 CFR 884.4160

FDA Product Code KNF: Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

Leading manufacturers include Gynesonics, Inc., KARL STORZ Endoscopy-America, Inc. and Aesculap, Inc..

44
Total
44
Cleared
187d
Avg days
1977
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 85d recently vs 191d historically

FDA 510(k) Cleared Coagulator-cutter, Endoscopic, Unipolar (and Accessories) Devices (Product Code KNF)

44 devices
1–24 of 44
Cleared Apr 02, 2025
Sonata Transcervical Fibroid Ablation System 2.2
K250705
Gynesonics, Inc.
Obstetrics & Gynecology · 23d
Cleared Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
K240503
Gynesonics, Inc.
Obstetrics & Gynecology · 147d
Cleared Dec 21, 2023
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
K233848
Gynesonics, Inc.
Obstetrics & Gynecology · 16d
Cleared Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
K222304
Gynesonics, Inc.
Obstetrics & Gynecology · 99d
Cleared Jun 17, 2021
Sonata Transcervical Fibroid Ablation System 2.2
K211535
Gynesonics, Inc.
Obstetrics & Gynecology · 30d
Cleared May 04, 2020
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
K193516
Gynesonics, Inc.
Obstetrics & Gynecology · 137d
Cleared Aug 15, 2018
Sonata Sonography-Guided Transcervical Fibroid Ablation System
K173703
Gynesonics, Inc.
Obstetrics & Gynecology · 254d
Cleared Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 09, 1995
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
K944862
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 129d
Cleared Jan 24, 1995
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 118d
Cleared Dec 15, 1994
KARL STORZ INSULATED SCISSORS
K944297
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 100d
Cleared Dec 15, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 100d

About Product Code KNF - Regulatory Context

510(k) Submission Activity

44 total 510(k) submissions under product code KNF since 1977, with 44 receiving FDA clearance (average review time: 187 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - KNF Product Code

Recent submissions under KNF have taken an average of 85 days to reach a decision - down from 191 days historically, suggesting improved FDA processing for this classification.

KNF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →