Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)UCleared 510(K)
- K241700Tenex 2nd Generation SystemUCleared 510(K)
- K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K233036Ultrasonic Surgical SystemUCleared 510(K)
- K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K231117neXus Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K221790HARMONIC 700 ShearsUCleared 510(K)
- K223770Sonopet 1Q 3 7cm 1Q LargeUCleared 510(K)
- K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5UCleared 510(K)
- K210567Ultrasonic Surgical SystemUCleared 510(K)
- K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K221235neXus Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K212614Ultrasonic Scalpel SystemUCleared 510(K)
- K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K212049Oclet TDS 1000UCleared 510(K)
- K213824Sonopet iQ Ultrasonic Aspirator SystemUCleared 510(K)
- K212060neXus Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceUCleared 510(K)
- K212750Ultrasonic Surgical Aspirator System, Model: XD880BUCleared 510(K)
- K211838Ultrasonic Bipolar Generator USG-410 with accessoriesUCleared 510(K)
- K211273Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayUCleared 510(K)
- K202299Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K200427Sonicision Cordless Ultrasonic DissectorUCleared 510(K)
- K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K192963Kogent Torus Ultrasonic AspiratorUCleared 510(K)
- K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthUCleared 510(K)
- K190281Ultrasonic Surgical SystemUCleared 510(K)
- K190160neXus Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K190070Sonopet iQ Ultrasonic Aspirator SystemUCleared 510(K)
- K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K181367Tenex Health TX System with the TXP MicroTipUCleared 510(K)
- K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideUCleared 510(K)
- K172691Ultrasonic GeneratorUCleared 510(K)
- K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemUCleared 510(K)
- K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthUCleared 510(K)
- K153371Sonicision Cordless Ultrasonic Dissection DeviceUCleared 510(K)
- K151136HARMONIC HOOKUCleared 510(K)
- K153299Tenex Health TX SystemUCleared 510(K)
- K150682CUSA Excel+UCleared 510(K)
- K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesUCleared 510(K)
- K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyUCleared 510(K)
- K150271Prime Adaptive Ultrasonic Scalpel SystemUCleared 510(K)
- K141668CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K141371SONICISION CORDLESS ULTRASONIC DISSECTORUCleared 510(K)
- K132522HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLEUCleared 510(K)
- K133314HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGYUCleared 510(K)
- K132512HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLEUCleared 510(K)
- K132612HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCEUCleared 510(K)
- K123640TX1 TISSUE REMOVAL SYSTEMUCleared 510(K)
- K121550HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGYUCleared 510(K)
- K120729HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23UCleared 510(K)
- K113570INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPUCleared 510(K)
- K111741INTEGRA(TM) CUSA NXT(TM) BONE TIPSUCleared 510(K)
- K102258CUSA NXT EXTENDED LENGTH TIPUCleared 510(K)
- K101797SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION TUCleared 510(K)
- K101561TX1 TISSUE REMOVAL SYSTEMUCleared 510(K)
- K100597HARMONIC FOCUS SHEARSUCleared 510(K)
- K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMUCleared 510(K)
- K072904SONOCA 180/195 WOUND CARE SYSTEMUCleared 510(K)
- K072203HARMONIC 10CM COMBINATION HOOK BLADEUCleared 510(K)
- K071669INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIPUCleared 510(K)
- K070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601UCleared 510(K)
- K070313MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K063531SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEMUCleared 510(K)
- K063192HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIPUCleared 510(K)
- K062544AR1000 ULTRASONIC WOUND THERAPY SYSTEMUCleared 510(K)
- K062471ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RFUCleared 510(K)
- K062000HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCHUCleared 510(K)
- K060245HARMONIC SCALPEL BLADES AND SHEARSUCleared 510(K)
- K053056HARMONIC SCALPEL BLADES AND SHEARSUCleared 510(K)
- K051947RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONEUCleared 510(K)
- K050776AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K050885OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURGUCleared 510(K)
- K051036HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36PUCleared 510(K)
- K042160SONOSURG TROCARUCleared 510(K)
- K042777HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36PUCleared 510(K)
- K042277SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEMUCleared 510(K)
- K041566SONOSURG ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K032424LOTUSUCleared 510(K)
- K032690MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K032066SONOSURG SYSTEMUCleared 510(K)
- K031523OLYMPUS ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K031305OLYMPUS ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K031710OLYMPUS ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K021962OLYMPUS ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3UCleared 510(K)
- K021929AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTEUCleared 510(K)
- K012753SORING GMBH SONOCA 180/190UCleared 510(K)
- K012176ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145UCleared 510(K)
- K012028ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5UCleared 510(K)
- K010898ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145UCleared 510(K)
- K010637SONOTOME ULTRASONIC ASPIRATOR TIPSUCleared 510(K)
- K010309SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATORUCleared 510(K)
- K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIUCleared 510(K)
- K002906ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07UCleared 510(K)
- K000927ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4UCleared 510(K)
- K000095OLYMPUS SONOSURG TROCAR XT3900 SYSTEMUCleared 510(K)
- K994280ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105UCleared 510(K)
- K993868THE SOUNDVASER DISSECTION SYSTEMUCleared 510(K)
- K993628OMNISONICS ULTRASONIC PROBESUCleared 510(K)
- K993054ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141UCleared 510(K)
- K991791SOUND VASER SYSTEMUCleared 510(K)
- K990572SONOTOMEUCleared 510(K)
- K990430ULTRACISION HARMONIC SCALPEL HAND PIECEUCleared 510(K)
- K983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODELUCleared 510(K)
- K983065MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEMUCleared 510(K)
- K980895ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATORUCleared 510(K)
- K983316ULTRACISION 5MM INSTRUMENTSUCleared 510(K)
- K980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTAUCleared 510(K)
- K982841MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4UCleared 510(K)
- K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMUCleared 510(K)
- K972114OLYMPUS SONOSURG SYSTEMUCleared 510(K)
- K980099ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))UCleared 510(K)
- K972148B.U.S. ENDOTRONUCleared 510(K)
- K971580UAS ULTRASONIC ASPIRATOR SYSTEMUCleared 510(K)
- K971609SCULPTUREUCleared 510(K)
- K971533VIBRA-SURGE SYSTEM MODEL VS2120UCleared 510(K)
- K970471MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)UCleared 510(K)
- K971302ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADEUCleared 510(K)
- K971861ULTRASONIC HAND INSTRUMENTSUCleared 510(K)
- K964742RONIX II ROTARY ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K964601CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORYUCleared 510(K)
- K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADEUCleared 510(K)
- K962525ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEMUCleared 510(K)
- K960374ULTRACUT 2000UCleared 510(K)
- K960040SHARPLAN ULTRA LAPAROSCOPIC HANDPIECEUCleared 510(K)
- K934628CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESSUCleared 510(K)
- K950945COOPER LASER SONICS CUSA MODEL 200UCleared 510(K)
- K942095SONOCA IIIUCleared 510(K)
- K931902CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.UCleared 510(K)
- K933559ALLIGER ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K933239CV720-727-000, MICROTIP AND FLUE PAKUCleared 510(K)
- K932094BOVIE ULTRASONIC SURGICAL ASPIRATORUCleared 510(K)
- K921251CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATORUCleared 510(K)
- K910696CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATORUCleared 510(K)
- K904010SURGICAL ASPIRATOR KITUCleared 510(K)
- K901974SELECTOR ULTRASONIC SURGICAL ASPIRATORUCleared 510(K)
- K901737SONOCA II ULTRASONIC SURGICAL DEVICEUCleared 510(K)
- K894600CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATORUCleared 510(K)
- K893926SONOCA ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K883091SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORSUCleared 510(K)
- K880814DX101 ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K880815DX101-T ULTRASONIC SURGICAL SYSTEMUCleared 510(K)
- K880166BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000UCleared 510(K)
- K864983CUSA SYSTEM 200 MACRO-DISSECTORUCleared 510(K)
- K852539SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOPUCleared 510(K)
- K851203R PAKUCleared 510(K)
- K830753NEEDLE GUIDE MODEL 21285AUCleared 510(K)
- K821820MCSC6PS MEDICAL COMPONENTSUCleared 510(K)
- K801623CAVITRON ULTRASONIC SURG. ASPIR. CUSAUCleared 510(K)
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211273
- 510(k) Type
- Special
- Applicant
- Ethicon Endo-Surgery, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/21/2021
- Days to Decision
- 24 days
- Submission Type
- Summary