FDA Product Code
FDA Product Code KNF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4160
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254303 | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | 2026-09-24 | Traditional | PDF ↗ |
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025-04-02 | Special | PDF ↗ |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024-07-17 | Traditional | PDF ↗ |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023-12-21 | Special | PDF ↗ |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022-11-08 | Traditional | PDF ↗ |
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021-06-17 | Special | PDF ↗ |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020-05-04 | Traditional | PDF ↗ |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018-08-15 | Traditional | PDF ↗ |
| K132135 | LINA GOLD LOOP HC | Lina Medical Aps | 2014-01-31 | Traditional | PDF ↗ |
| K121343 | MODULAP LOOP | Atc Technologies, Inc. | 2013-06-14 | Traditional | PDF ↗ |
| K103726 | JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS | Integra LifeSciences Corporation | 2012-02-08 | Traditional | PDF ↗ |
| K092897 | LAP LOOP | Medsys, S.A. | 2010-02-01 | Traditional | PDF ↗ |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007-10-30 | Traditional | PDF ↗ |
| K022979 | LAPARETTE, MODEL LAP J L S H N | Instruments Medicaux G.B., Inc. | 2002-12-18 | Special | PDF ↗ |
| K010752 | AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY | Aesculap, Inc. | 2001-06-11 | Traditional | PDF ↗ |
| K003405 | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO | Highland / Marietta, Inc. | 2001-05-07 | Traditional | PDF ↗ |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Hdc Corp. | 2001-03-15 | Special | PDF ↗ |
| K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | 1998-07-10 | Traditional | PDF ↗ |
| K970961 | VAPORIZATION ELECTRODES | Richard Wolf Medical Instruments Corp. | 1998-04-10 | Traditional | PDF ↗ |
| K972856 | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS | Rocket Medical Plc | 1998-02-11 | Traditional | PDF ↗ |
| K971838 | MICRO ELECTRODES | CooperSurgical, Inc. | 1997-11-05 | Traditional | PDF ↗ |
| K971146 | LAPARETTE | Rd Chus, Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K964594 | VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) | Circon Corp. | 1997-08-15 | Traditional | PDF ↗ |
| K971621 | RESISTICK SOLID LAPAROSCOPIC ELECTRODES | Aaron Medical Industries | 1997-06-20 | Traditional | PDF ↗ |
| K964441 | FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU | Gynecare Innovation Center | 1997-03-28 | Traditional | PDF ↗ |
| K953242 | SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES | Symbiosis Corp. | 1995-10-06 | Traditional | PDF ↗ |
| K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS | American Hydro-Surgical Instruments, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | American Hydro-Surgical Instruments, Inc. | 1995-06-16 | Traditional | PDF ↗ |
| K944862 | KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES | KARL STORZ Endoscopy-America, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K944793 | KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES | KARL STORZ Endoscopy-America, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K941207 | MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES | New Eder Corp. | 1995-01-24 | Traditional | PDF ↗ |
| K944300 | KARL STORZ INSULATED BIOPSY FORCEPS | KARL STORZ Endoscopy-America, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K944297 | KARL STORZ INSULATED SCISSORS | KARL STORZ Endoscopy-America, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K933300 | GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. | Lyle Howard Corp. | 1994-09-30 | Traditional | PDF ↗ |
| K921727 | CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 | Viggo-Spectramed | 1994-05-10 | Traditional | PDF ↗ |
| K932456 | JARIT SURGICAL INSTRUMENTS | J. Jamner Surgical Instruments, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K921686 | ENDOMED LAPAROSCOPY INSTRUMENTS | Buckman Co., Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K935947 | HI-TOPS ELECTRODES 14-8000 | W. J. Medical Instruments, Inc. | 1994-02-28 | Traditional | PDF ↗ |
| K924200 | REFLEX(R) ESC | Richard-Allan Medical Ind., Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K902658 | GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES | Gynescope Corp. | 1990-09-19 | Traditional | PDF ↗ |
| K871960 | ELECTRO-GYNE ELECTROSURGICAL GENERATOR | Cabot Medical Corp. | 1987-07-10 | Traditional | PDF ↗ |
| K780954 | SCISSORS, HOOK, ELECTROSURGICAL | Kli | 1978-06-22 | Traditional | PDF ↗ |
| K780955 | SCISSORS, HOOK, ELECTROSURGICAL | Kli | 1978-06-22 | Traditional | PDF ↗ |
| K772220 | PROBE, COAGULATION ACCESSORY | Kli | 1977-12-13 | Traditional | PDF ↗ |
Product code KNF · Class II · Obstetrics/Gynecology. Data: openFDA.