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 Kli.

45
Total
45
Cleared
188d
Avg days
1977
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 145d recently vs 190d historically

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

45 devices
1–24 of 45
Cleared Sep 24, 2026
KARL STORZ SUPRALOOP
K254303
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 267d
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 Jan 31, 2014
LINA GOLD LOOP HC
K132135
Lina Medical Aps
Obstetrics & Gynecology · 205d
Cleared Jun 14, 2013
MODULAP LOOP
K121343
Atc Technologies, Inc.
Obstetrics & Gynecology · 406d
Cleared Feb 08, 2012
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS
K103726
Integra LifeSciences Corporation
Obstetrics & Gynecology · 413d
Cleared Feb 01, 2010
LAP LOOP
K092897
Medsys, S.A.
Obstetrics & Gynecology · 133d
Cleared Oct 30, 2007
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315
Lina Medical Aps
Obstetrics & Gynecology · 271d
Cleared Dec 18, 2002
LAPARETTE, MODEL LAP J L S H N
K022979
Instruments Medicaux G.B., Inc.
Obstetrics & Gynecology · 100d
Cleared Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared May 07, 2001
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
K003405
Highland / Marietta, Inc.
Obstetrics & Gynecology · 187d
Cleared Mar 15, 2001
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
K010425
Hdc Corp.
Obstetrics & Gynecology · 30d
Cleared Jul 17, 1998
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K981463
Omnitech Systems, Inc.
Obstetrics & Gynecology · 85d
Cleared Jul 10, 1998
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464
Omnitech Systems, Inc.
Obstetrics & Gynecology · 78d
Cleared Apr 10, 1998
VAPORIZATION ELECTRODES
K970961
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 389d
Cleared Feb 11, 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856
Rocket Medical Plc
Obstetrics & Gynecology · 194d
Cleared Nov 05, 1997
MICRO ELECTRODES
K971838
CooperSurgical, Inc.
Obstetrics & Gynecology · 170d
Cleared Aug 25, 1997
LAPARETTE
K971146
Rd Chus, Inc.
Obstetrics & Gynecology · 150d
Cleared Aug 15, 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
K964594
Circon Corp.
Obstetrics & Gynecology · 273d

About Product Code KNF - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code KNF since 1977, with 45 receiving FDA clearance (average review time: 188 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 145 days to reach a decision - down from 190 days historically, suggesting improved FDA processing for this classification.

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