Atlas FDA

KNF

44 FDA 510(k) clearances · Product code

130 daysmedian time to decision
413 days90th percentile
44clearances measured

FDA profile

Official device name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4160
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2019: 18 · 2020: 19 · 2022: 16 · 2023: 33 · 2025: 94 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Sonata Transcervical Fibroid Ablation System 2.2 (K250705)Gynesonics, Inc.2025-04-02
Sonata Transcervical Fibroid Ablation System 2.2 (K240503)Gynesonics, Inc.2024-07-17
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (K233848)Gynesonics, Inc.2023-12-21
Sonata Transcervical Fibroid Ablation System 2.2 (K222304)Gynesonics, Inc.2022-11-08
Sonata Transcervical Fibroid Ablation System 2.2 (K211535)Gynesonics, Inc.2021-06-17
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (K193516)Gynesonics, Inc.2020-05-04
Sonata Sonography-Guided Transcervical Fibroid Ablation System (K173703)Gynesonics, Inc.2018-08-15
LINA GOLD LOOP HC (K132135)Lina Medical Aps2014-01-31
MODULAP LOOP (K121343)Atc Technologies, Inc.2013-06-14
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (K103726)Integra LifeSciences Corporation2012-02-08
LAP LOOP (K092897)Medsys, S.A.2010-02-01
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (K070315)Lina Medical Aps2007-10-30
LAPARETTE, MODEL LAP J L S H N (K022979)Instruments Medicaux G.B., Inc.2002-12-18
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY (K010752)Aesculap, Inc.2001-06-11
ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO (K003405)Highland / Marietta, Inc.2001-05-07
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (K010425)Hdc Corp.2001-03-15
OMNITECH RESECTOSCOPE ROLLER ELECTRODE (K981463)Omnitech Systems, Inc.1998-07-17
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (K981464)Omnitech Systems, Inc.1998-07-10
VAPORIZATION ELECTRODES (K970961)Richard Wolf Medical Instruments Corp.1998-04-10
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS (K972856)Rocket Medical Plc1998-02-11
MICRO ELECTRODES (K971838)CooperSurgical, Inc.1997-11-05
LAPARETTE (K971146)Rd Chus, Inc.1997-08-25
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) (K964594)Circon Corp.1997-08-15
RESISTICK SOLID LAPAROSCOPIC ELECTRODES (K971621)Aaron Medical Industries1997-06-20
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU (K964441)Gynecare Innovation Center1997-03-28
SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (K953242)Symbiosis Corp.1995-10-06
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS (K952070)American Hydro-Surgical Instruments, Inc.1995-07-26
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (K950499)American Hydro-Surgical Instruments, Inc.1995-06-16
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES (K944862)KARL STORZ Endoscopy-America, Inc.1995-02-09
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES (K944793)KARL STORZ Endoscopy-America, Inc.1995-01-24
MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES (K941207)New Eder Corp.1995-01-24
KARL STORZ INSULATED BIOPSY FORCEPS (K944300)KARL STORZ Endoscopy-America, Inc.1994-12-15
KARL STORZ INSULATED SCISSORS (K944297)KARL STORZ Endoscopy-America, Inc.1994-12-15
GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. (K933300)Lyle Howard Corp.1994-09-30
CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 (K921727)Viggo-Spectramed1994-05-10
JARIT SURGICAL INSTRUMENTS (K932456)J. Jamner Surgical Instruments, Inc.1994-04-21
ENDOMED LAPAROSCOPY INSTRUMENTS (K921686)Buckman Co., Inc.1994-03-30
HI-TOPS ELECTRODES 14-8000 (K935947)W. J. Medical Instruments, Inc.1994-02-28
REFLEX(R) ESC (K924200)Richard-Allan Medical Ind., Inc.1994-02-22
GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (K902658)Gynescope Corp.1990-09-19
ELECTRO-GYNE ELECTROSURGICAL GENERATOR (K871960)Cabot Medical Corp.1987-07-10
SCISSORS, HOOK, ELECTROSURGICAL (K780955)Kli1978-06-22
SCISSORS, HOOK, ELECTROSURGICAL (K780954)Kli1978-06-22
PROBE, COAGULATION ACCESSORY (K772220)Kli1977-12-13

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Every clearance here is in the API, with alerts when new ones post.