Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
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- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HLDEngine, Trephine, Accessories, Gas-Powered1Product Code
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered2Product Code
- FCTHeadlight, Fiberoptic Focusing2Product Code
- FSRLight, Headband, Surgical2Product Code
- FTZLocator, Magnetic1Product Code
- HMQMarker, Sclera1Product Code
- HMRMarker, Ocular1Product Code
- HMSDrum, Eye Knife Test1Product Code
- HMXCannula, Ophthalmic1Product Code
- HMYKeratome, Battery-Powered1Product Code
- HMZTrabeculotome1Product Code
- HNASpud, Ophthalmic1Product Code
- HNBSpoon, Ophthalmic1Product Code
- HNCSpecula, Ophthalmic1Product Code
- HNDSpatula, Ophthalmic1Product Code
- HNESnare, Enucleating1Product Code
- HNFScissors, Ophthalmic1Product Code
- HNGRongeur, Lachrymal Sac1Product Code
- HNHRing, Ophthalmic (Flieringa)1Product Code
- HNIRetractor, Ophthalmic1Product Code
- HNJPunch, Corneo-Scleral1Product Code
- HNKProbe, Trabeculotomy1Product Code
- HNLProbe, Lachrymal1Product Code
- HNMNeedle, Ophthalmic Suturing1Product Code
- HNNKnife, Ophthalmic1Product Code
- HNOKeratome, Ac-Powered1Product Code
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- HNSExpressor1Product Code
- HNTErisophake1Product Code
- HNWDilator, Lachrymal1Product Code
- HNXDepressor, Orbital1Product Code
- HNYCystotome1Product Code
- HNZCurette, Ophthalmic1Product Code
- HOACompressor, Orbital1Product Code
- HOBClamp, Muscle, Ophthalmic1Product Code
- HOCClip, Iris Retractor1Product Code
- HODClamp, Eyelid, Ophthalmic1Product Code
- HOECaliper, Ophthalmic1Product Code
- HOFBurr, Corneal, Manual1Product Code
- HOGBurr, Corneal, Battery-Powered1Product Code
- HOHSpectacle, Operating (Loupe), Ophthalmic1Product Code
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1Product Code
- HOZSponge, Ophthalmic2Product Code
- K132796SUNTOUCH EYE SPEAR2Cleared 510(K)
- K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS2Cleared 510(K)
- K091240ALPHAMED SURGICAL SPEAR, MODEL 70-50002Cleared 510(K)
- K082460CENEFOM PVA SURGICAL SPEAR2Cleared 510(K)
- K012196ULTRACELL ABSORBENT STICK2Cleared 510(K)
- K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES2Cleared 510(K)
- K003842PRESCOTT'S SURGICAL SPEAR2Cleared 510(K)
- K002279ML EYE SPEAR, MODEL ML 27 ES2Cleared 510(K)
- K993883M-PACT CORNEAL LIGHT SHIELD2Cleared 510(K)
- K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE2Cleared 510(K)
- K990749SOF-SUCTION FLUID EVACUATION SYSTEM2Cleared 510(K)
- K982599THE FREMSTAD RING2Cleared 510(K)
- K974313HYDROFERA SURGICAL SPEAR2Cleared 510(K)
- K972633ULTRACELL SUCTION SPONGE2Cleared 510(K)
- K972693DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR2Cleared 510(K)
- K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK2Cleared 510(K)
- K964855EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD2Cleared 510(K)
- K946016IVALON OPHTHALMIC SPONGE2Cleared 510(K)
- K950241OPHTHALMIC SPONGES2Cleared 510(K)
- K942642SURGI-WIPE2Cleared 510(K)
- K933872VISI-SPEAR EYE SPONGE2Cleared 510(K)
- K923922SURGICAL SPEARS2Cleared 510(K)
- K920354OPHTHALMIC SPONGES2Cleared 510(K)
- K910707OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS2Cleared 510(K)
- K902750VISI-SWAB OPHTALMIC SPONGE2Cleared 510(K)
- K900786VISI-SORB ABSORBANT STICK2Cleared 510(K)
- K897034K-SPONGE2Cleared 510(K)
- K896705VISITEC MICRO-SPONGE SPEARS2Cleared 510(K)
- K896084MICROSPEARS2Cleared 510(K)
- K896004ALCON SURGICAL SPONGE2Cleared 510(K)
- K885232FLUID DRAINAGE WICK2Cleared 510(K)
- K872612SOLOS EYESITE SPONGES2Cleared 510(K)
- K852055ASCON OPHTHALMIC SPONGE2Cleared 510(K)
- K850340EYE PROCEDURE PACK2Cleared 510(K)
- K842983AMPCO OPTHALMIC TRAY2Cleared 510(K)
- K842601PRE-OPERATIVE OPHTHALMIC DRESSING TRAY2Cleared 510(K)
- K842990STERILE EYE SURGERY KITS2Cleared 510(K)
- K850050PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK2Cleared 510(K)
- K850883SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-112Cleared 510(K)
- K841721OPERAID SURGICAL DRAIN2Cleared 510(K)
- K840471EYE SPEAR2Cleared 510(K)
- K834356EYE SPONGE OR SPEAR2Cleared 510(K)
- K830262FLORET OPHTHALMIC EYE SPEAR2Cleared 510(K)
- K802794PRO-OPHTA STICKS2Cleared 510(K)
- K780987SOFT SILICONE ELASTOMER SPONGE EXPLANT2Cleared 510(K)
- K780257MICROSPEARS2Cleared 510(K)
- K761155CELLULOSE EYE STICK2Cleared 510(K)
- HPMLocator, Metal, Electronic2Product Code
- HPNMagnet, Permanent1Product Code
- HPOMagnet, Ac-Powered2Product Code
- HPPHeadlamp, Operating, Battery-Operated1Product Code
- HPQHeadlamp, Operating, Ac-Powered2Product Code
- HPSUnit, Cryophthalmic2Product Code
- HPYUnit, Electrolysis, Battery-Powered, Ophthalmic1Product Code
- HQAUnit, Cryotherapy, Ophthalmic2Product Code
- HQBPhotocoagulator And Accessories2Product Code
- HQCUnit, Phacofragmentation2Product Code
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- HQOUnit, Cautery, Thermal, Ac-Powered2Product Code
- HQPUnit, Cautery, Thermal, Battery-Powered2Product Code
- HQQApparatus, Cautery, Radiofrequency, Battery-Powered2Product Code
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered2Product Code
- HQSBurr, Corneal, Ac-Powered1Product Code
- HRFEngine, Trephine, Accessories, Battery-Powered1Product Code
- HRGEngine, Trephine, Accessories, Ac-Powered1Product Code
- HRHTrephine, Manual, Ophthalmic1Product Code
- HRJTable, Instrument, Powered, Ophthalmic1Product Code
- HRKTable, Instrument, Manual, Ophthalmic1Product Code
- HRNUnit, Cryophthalmic, Ac-Powered2Product Code
- HROUnit, Electrolysis, Ac-Powered, Ophthalmic2Product Code
- HRPPen, Marking, Surgical1Product Code
- KYBLens, Guide, Intraocular1Product Code
- KYGDevice, Irrigation, Ocular Surgery1Product Code
- LCCApplicator, Ocular Pressure2Product Code
- LPOGases Used Within Eye To Place Pressure On Detached Retina3Product Code
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser2Product Code
- LWLFluid, Intraocular3Product Code
- LXPPlug, Scleral2Product Code
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla2Product Code
- LZPAid, Surgical, Viscoelastic3Product Code
- MLZVitrectomy, Instrument Cutter2Product Code
- MMCDilator, Expansive Iris (Accessory)2Product Code
- MOECollagen Corneal Shield1Product Code
- MSRTubing, Replacement, Phacofragmentation Unit2Product Code
- MSSFolders And Injectors, Intraocular Lens (Iol)1Product Code
- MUSFluidic, Phacoemulsification/Phacofragmentation2Product Code
- MXOLaser, System, Phacolysis2Product Code
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal1Product Code
- MYDKeratome, Water Jet1Product Code
- NCEInjector, Capsular Tension Ring1Product Code
- NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered2Product Code
- NGYCannula, Trocar, Ophthalmic1Product Code
- NKXNeedle, Phacoemulsification, Reprocessed2Product Code
- NKYBlade, Keratome, Reprocessed1Product Code
- NLAKnife, Ophthalmic, Reprocessed1Product Code
- NVBIntraocular, Pressure Measuring Device3Product Code
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal1Product Code
- OHXBurr, Corneal, Ac-Powered, Rust Ring Removal1Product Code
- OJKEye Tray2Product Code
- OOEOphthalmic Femtosecond Laser2Product Code
- OTZGraft Insertion Instrument For Endothelial Keratoplasty1Product Code
- PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered2Product Code
- PZGSurgical Eye Tray1Product Code
- QDVIol Tray1Product Code
- QDWPhaco Kit2Product Code
- QDYVitrectomy Kit2Product Code
- QGJCorneal Inlay Inserter Handle1Product Code
- QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Product Code
- PYUSponge, Eyelid Cleaning, Powered1Product Code
- QUQKnife, Intraocular Pressure Lowering2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SOFT SILICONE ELASTOMER SPONGE EXPLANT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K780987
- 510(k) Type
- Traditional
- Applicant
- MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/28/1978
- Days to Decision
- 106 days