Product code KNF
- Device name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4160
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025-04-02 |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024-07-17 |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023-12-21 |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022-11-08 |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021-06-17 |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020-05-04 |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018-08-15 |
| K132135 | LINA GOLD LOOP HC | Lina Medical Aps | 2014-01-31 |
| K121343 | MODULAP LOOP | Atc Technologies, Inc. | 2013-06-14 |
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | 2012-02-08 |
| K092897 | LAP LOOP | Medsys, S.A. | 2010-02-01 |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007-10-30 |
| K022979 | LAPARETTE, MODEL LAP J L S H N | Instruments Medicaux G.B., Inc. | 2002-12-18 |
| K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-06-11 |
| K003405 | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO | Highland / Marietta, Inc. | 2001-05-07 |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Hdc Corp. | 2001-03-15 |
| K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | 1998-07-17 |
| K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | 1998-07-10 |
| K970961 | VAPORIZATION ELECTRODES | Richard Wolf Medical Instruments Corp. | 1998-04-10 |
| K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS | Rocket Medical Plc | 1998-02-11 |
| K971838 | MICRO ELECTRODES | CooperSurgical, Inc. | 1997-11-05 |
| K971146 | LAPARETTE | Rd Chus, Inc. | 1997-08-25 |
| K964594 | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) | Circon Corp. | 1997-08-15 |
| K971621 | RESISTICK SOLID LAPAROSCOPIC ELECTRODES | Aaron Medical Industries | 1997-06-20 |
| K964441 | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU | Gynecare Innovation Center | 1997-03-28 |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | Symbiosis Corp. | 1995-10-06 |
| K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS | American Hydro-Surgical Instruments, Inc. | 1995-07-26 |
| K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | American Hydro-Surgical Instruments, Inc. | 1995-06-16 |
| K944862 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES | KARL STORZ Endoscopy-America, Inc. | 1995-02-09 |
| K941207 | MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES | New Eder Corp. | 1995-01-24 |
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| 10381780129424 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
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| 10381780129288 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780129271 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |
| 10381780129264 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-11 |