Panels › Obstetrics/Gynecology › Product code KNF · Class 2
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation 884.4160
1510(k)s in 12 months (45 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in KNF
| Company | 510(k)s | Recalls |
|---|---|---|
| Gynesonics, Inc. | 7 | 0 |
| Lina Medical Aps | 2 | 3 |
| KARL STORZ Endoscopy-America, Inc. | 4 | 0 |
| Kli | 3 | 0 |
| American Hydro-Surgical Instruments, Inc. | 2 | 0 |
| Integra LifeSciences Corporation | 1 | 1 |
| Omnitech Systems, Inc. | 2 | 0 |
| Aaron Medical Industries | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| Atc Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K254303 | KARL STORZ SUPRALOOP Karl Storz SE & CO. KG | KNF |
| Apr 2, 2025 | K250705 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Jul 17, 2024 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Dec 21, 2023 | K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) Gynesonics, Inc. | KNF |
| Nov 8, 2022 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| Jun 17, 2021 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 Gynesonics, Inc. | KNF |
| May 4, 2020 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 Gynesonics, Inc. | KNF |
| Aug 15, 2018 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. | KNF |
| Jan 31, 2014 | K132135 | LINA GOLD LOOP HC Lina Medical Aps | KNF |
| Jun 14, 2013 | K121343 | MODULAP LOOP Atc Technologies, Inc. | KNF |
| Feb 8, 2012 | K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS Integra LifeSciences Corporation | KNF |
| Feb 1, 2010 | K092897 | LAP LOOP Medsys, S.A. | KNF |
| Oct 30, 2007 | K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 Lina Medical Aps | KNF |
| Dec 18, 2002 | K022979 | LAPARETTE, MODEL LAP J L S H N Instruments Medicaux G.B., Inc., CA | KNF |
| Jun 11, 2001 | K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY Aesculap, Inc. | KNF |
| May 7, 2001 | K003405 | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO Highland / Marietta, Inc. | KNF |
| Mar 15, 2001 | K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) Hdc Corp. | KNF |
| Jul 17, 1998 | K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE Omnitech Systems, Inc. | KNF |
| Jul 10, 1998 | K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE Omnitech Systems, Inc. | KNF |
| Apr 10, 1998 | K970961 | VAPORIZATION ELECTRODES Richard Wolf Medical Instruments Corp. | KNF |
| Feb 11, 1998 | K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS Rocket Medical Plc, GB | KNF |
| Nov 5, 1997 | K971838 | MICRO ELECTRODES CooperSurgical, Inc. | KNF |
| Aug 25, 1997 | K971146 | LAPARETTE Rd Chus, Inc. | KNF |
| Aug 15, 1997 | K964594 | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) Circon Corp. | KNF |
| Jun 20, 1997 | K971621 | RESISTICK SOLID LAPAROSCOPIC ELECTRODES Aaron Medical Industries | KNF |
| Mar 28, 1997 | K964441 | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU Gynecare Innovation Center | KNF |
| Oct 6, 1995 | K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES Symbiosis Corp. | KNF |
| Jul 26, 1995 | K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS American Hydro-Surgical Instruments, Inc. | KNF |
| Jun 16, 1995 | K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS American Hydro-Surgical Instruments, Inc. | KNF |
| Feb 9, 1995 | K944862 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES KARL STORZ Endoscopy-America, Inc. | KNF |
| Jan 24, 1995 | K944793 | KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES KARL STORZ Endoscopy-America, Inc. | KNF |
| Jan 24, 1995 | K941207 | MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES New Eder Corp. | KNF |
| Dec 15, 1994 | K944300 | KARL STORZ INSULATED BIOPSY FORCEPS KARL STORZ Endoscopy-America, Inc. | KNF |
| Dec 15, 1994 | K944297 | KARL STORZ INSULATED SCISSORS KARL STORZ Endoscopy-America, Inc. | KNF |
| Sep 30, 1994 | K933300 | GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. Lyle Howard Corp. | KNF |
| May 10, 1994 | K921727 | CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 Viggo-Spectramed | KNF |
| Apr 21, 1994 | K932456 | JARIT SURGICAL INSTRUMENTS J. Jamner Surgical Instruments, Inc. | KNF |
| Mar 30, 1994 | K921686 | ENDOMED LAPAROSCOPY INSTRUMENTS Buckman Co., Inc. | KNF |
| Feb 28, 1994 | K935947 | HI-TOPS ELECTRODES 14-8000 W. J. Medical Instruments, Inc. | KNF |
| Feb 22, 1994 | K924200 | REFLEX(R) ESC Richard-Allan Medical Ind., Inc. | KNF |
| Sep 19, 1990 | K902658 | GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES Gynescope Corp. | KNF |
| Jul 10, 1987 | K871960 | ELECTRO-GYNE ELECTROSURGICAL GENERATOR Cabot Medical Corp. | KNF |
| Jun 22, 1978 | K780955 | SCISSORS, HOOK, ELECTROSURGICAL Kli | KNF |
| Jun 22, 1978 | K780954 | SCISSORS, HOOK, ELECTROSURGICAL Kli | KNF |
| Dec 13, 1977 | K772220 | PROBE, COAGULATION ACCESSORY Kli | KNF |
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