Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- K091187GRACE DYNAMIC TORP2Cleared 510(K)
- K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 22Cleared 510(K)
- K043375FISCH TITANIUM MIDDLE EAR PROSTHESES2Cleared 510(K)
- K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM2Cleared 510(K)
- K030492TITANIUM OSSICULAR REPLACMENT SYSTEM2Cleared 510(K)
- K002378MODULAR PORP AND TORP MODEL TBD2Cleared 510(K)
- K001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON2Cleared 510(K)
- K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES2Cleared 510(K)
- K001902BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD2Cleared 510(K)
- K993583ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM2Cleared 510(K)
- K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES2Cleared 510(K)
- K990601BOJRAB MICRO-TORP, MODEL 7014-58452Cleared 510(K)
- K981088MILLS COLUMELLA PROSTHESIS2Cleared 510(K)
- K972735TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)2Cleared 510(K)
- K963899CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)2Cleared 510(K)
- K972585AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN2Cleared 510(K)
- K955615MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS2Cleared 510(K)
- K954518TREBAY TOTAL RECTANGULAR HEAD2Cleared 510(K)
- K952549RICHARDS TORP2Cleared 510(K)
- K950927HAPEX MALLEABLE TORP2Cleared 510(K)
- K945106MICROMED TOTAL REGULAR AND PARTIAL OFFSET2Cleared 510(K)
- K934107BLACK OVAL-TOP TORP/PORP2Cleared 510(K)
- K913286H/A TOTAL-REGULAR, H/A TOTAL-OFFSET2Cleared 510(K)
- K911583IONOS(R) OSSICLE 5MM & 7MM2Cleared 510(K)
- K904239SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES2Cleared 510(K)
- K895815MICROTEK TOTAL OSSICULAR PROTHESIS2Cleared 510(K)
- K884884OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL2Cleared 510(K)
- K885201OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT2Cleared 510(K)
- K864444SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE2Cleared 510(K)
- K864443EGG-TOP TORP AND EGG-TOP PORP2Cleared 510(K)
- K843461BIOGLASS OSSICULAR RECONSTRUCTION PROSTH2Cleared 510(K)
- K823917PARTIAL OSSICULAR REPLACEMENT2Cleared 510(K)
- K823919TOTAL OSSICULAR REPLACEMENT2Cleared 510(K)
- K823918AUSTIN MODIFIED PARTIAL OSSICULAR RE-2Cleared 510(K)
- K823912AUSTIN MODIFIED TOTAL OSSICULAR REPLACE2Cleared 510(K)
- K810707CERAVITAL CERAMIC OSSICULAR REPL. PROS.2Cleared 510(K)
- K760433SHEA TORP, OTOLOGY IMPLANT2Cleared 510(K)
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- 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—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- PathologyReview Panel
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HAPEX MALLEABLE TORP
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K950927
- 510(k) Type
- Traditional
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/21/1995
- Days to Decision
- 20 days
- Submission Type
- Summary