Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating1Product Code
- HRRScissors, Orthopedic, Surgical1Product Code
- HRTStripper, Surgical1Product Code
- HSPSplint, Traction1Product Code
- HSQBelt, Pelvic, Traction1Product Code
- HTHProtractor1Product Code
- HTJGauge, Depth1Product Code
- HTOReamer1Product Code
- HTPFile1Product Code
- HTQBroach1Product Code
- HTSKnife, Orthopedic1Product Code
- HTTBurr, Orthopedic1Product Code
- HTWBit, Drill1Product Code
- HTXRongeur1Product Code
- HWAImpactor1Product Code
- HWBExtractor1Product Code
- HWDStarter, Bone Screw1Product Code
- HWICorkscrew1Product Code
- HWJAwl1Product Code
- HWKTrephine1Product Code
- HWLSet, Hollow Mill1Product Code
- HWNInstrument, Compression1Product Code
- HWOSkid, Bone1Product Code
- HWPPunch, Femoral Neck1Product Code
- HWQPasser1Product Code
- HWRDriver, Prosthesis1Product Code
- HWTTemplate1Product Code
- HWWCountersink1Product Code
- HWXTap, Bone1Product Code
- HXBProbe1Product Code
- HXCWrench1Product Code
- HXEFork1Product Code
- HXGTamp1Product Code
- HXIPasser, Wire, Orthopedic1Product Code
- HXJStaple Driver1Product Code
- HXKHolder, Needle; Orthopedic1Product Code
- HXNApplier, Cerclage1Product Code
- HXOPusher, Socket1Product Code
- HXPInstrument, Bending Or Contouring1Product Code
- HXQCrimper, Pin1Product Code
- HXSTwister, Wire1Product Code
- HXWBender1Product Code
- HXXScrewdriver1Product Code
- HXYBrace, Drill1Product Code
- HXZCutter, Wire1Product Code
- JDXInstrument, Surgical, Sonic And Accessory/Attachment2Product Code
- JDYEvacuator, Vapor, Cement Monomer1Product Code
- JDZMixer, Cement, For Clinical Use1Product Code
- KIHDispenser, Cement1Product Code
- KIITube, Cement Ventilation1Product Code
- KILPositioner, Socket1Product Code
- KQZComponent, Traction, Non-Invasive1Product Code
- KTZCaliper1Product Code
- LGFComponent, Cast1Product Code
- LGGInstrument, Cast Application/Removal, Manual1Product Code
- LGHInstrument, Cast Removal, Ac-Powered1Product Code
- LXHOrthopedic Manual Surgical Instrument1Product Code
- LYQAccessories, Fixation, Spinal Intervertebral Body1Product Code
- LYSBone Mill1Product Code
- LZVSystem, Cement Removal Extraction2Product Code
- OARInjector, Vertebroplasty (Does Not Contain Cement)1Product Code
- OCJSpinal Channeling Instrument, Vertebroplasty1Product Code
- QBOInstruments Designed For Press-Fit Osteochondral Implants2Product Code
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1Product Code
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1Product Code
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment1Product Code
- K163308SMARTO1Cleared 510(K)
- K112599INSURGICAL SINGLE USE POWER EQUIPMENT1Cleared 510(K)
- K101563SMARTO1Cleared 510(K)
- K972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT1Cleared 510(K)
- K970378STRYKER 2115 REPLACEMENT BATTERY (2115)1Cleared 510(K)
- K960711ACUMED BONE GRAFT SYSTEM1Cleared 510(K)
- K951450SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY1Cleared 510(K)
- K944488S & S ORTHOPEDIC WIRE DRIVER 7011Cleared 510(K)
- K941285ARTHREX GRAFT HARVESTING KIT1Cleared 510(K)
- K933101THE OSTEOMED B POWER SYSTEM AND ACCESSORIES1Cleared 510(K)
- K933337R AND D BATTERY REPLACEMENT1Cleared 510(K)
- K931395SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM1Cleared 510(K)
- K9323073M MAXI-DRIVER II DBATTERY POWERED SYSTEM1Cleared 510(K)
- K884839MODIFIED SAW BLADES TO THE SAGITAL SAW1Cleared 510(K)
- K873766STERNAL POWER AWL1Cleared 510(K)
- K864137LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III1Cleared 510(K)
- K850789FLUTED SUCTION MENISCAL CUTTER1Cleared 510(K)
- K844162EZ 5051Cleared 510(K)
- K844163EZ 5021Cleared 510(K)
- K822790MICRO-CRAFT OSCILLATING SAW HANDPIECE1Cleared 510(K)
- K820367INTRA-ARTICULAR SURGICAL SYSTEM1Cleared 510(K)
- K800314POWER PACK1Cleared 510(K)
- K800315DUAL MPC CHARGER1Cleared 510(K)
- K800313SAGITTAL SAW1Cleared 510(K)
- K800312150 DRIVER/REAMER1Cleared 510(K)
- K800311450 DRILL/800 DRILL1Cleared 510(K)
- K790063DRILL, CORDLESS SURGICAL1Cleared 510(K)
- K780645HMD-2000 BATTERY-POWERED MINI-DRILL, THE1Cleared 510(K)
- K771218INTRA-ARTICULAR SHAVER1Cleared 510(K)
- LXIGuide, Drill, Ligament1Product Code
- OJHOrthopedic Tray1Product Code
- PPPDisposable Joint Aspiration/Injection Kit1Product Code
- SAMBattery-Powered Instruments Charged Through Sterile Barriers1Product Code
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
POWER PACK
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K800314
- 510(k) Type
- Traditional
- Applicant
- BLACK & DECKER(TM)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/19/1980
- Days to Decision
- 36 days