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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- HDOValve, Tubal Occlusion3Product Code
- HDRCap, Cervical2Product Code
- HDTDevice, Intrauterine, Contraceptive And Introducer3Product Code
- HDWDiaphragm, Contraceptive (And Accessories)2Product Code
- HEBTampon, Menstrual, Unscented2Product Code
- HECInsufflator, Vaginal1Product Code
- HEDDouche Apparatus, Vaginal, Therapeutic1Product Code
- HEESet, Anesthesia, Paracervical2Product Code
- HEGSet, Anesthesia, Pudendal2Product Code
- HEHChamber, Decompression, Abdominal3Product Code
- HFYBand, Tubal Occlusion3Product Code
- HGBClip, Tubal Occlusion3Product Code
- HGFSource, Abortion Unit, Vacuum2Product Code
- HGGController, Abortion Unit, Vacuum2Product Code
- HGHCannula, Suction, Uterine2Product Code
- HGXPump, Breast, Powered2Product Code
- HGYPump, Breast, Non-Powered1Product Code
- HGZHeater, Perineal, Direct Contact2Product Code
- HHAHeater, Perineal, Radiant, Non-Contact2Product Code
- HHDPad, Menstrual, Unscented1Product Code
- HHECup, Menstrual2Product Code
- HHISystem, Abortion, Vacuum2Product Code
- HHLPad, Menstrual, Scented2Product Code
- HHQSystem, Abortion, Metreurynter-Balloon3Product Code
- HHSTranscervical Contraceptive Tubal Occlusion Device3Product Code
- HIIStimulator, Vaginal, Muscle, Powered, For Therapeutic Use3Product Code
- HILTampon, Menstrual, Scented, Deodorized2Product Code
- HISCondom2Product Code
- K250034Natural rubber latex male condom2Cleared 510(K)
- K243421Lelo Hex Lubricated Natural Rubber Latex Condom2Cleared 510(K)
- K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)2Cleared 510(K)
- K2435840.04 ZERO ZERO FOUR Male Latex Condom2Cleared 510(K)
- K232279LifeStyles NRL Textured Condom2Cleared 510(K)
- K230049SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT2Cleared 510(K)
- K222611Male Latex Condoms2Cleared 510(K)
- K220489Durex Patronus CloseFit, Durex Patronus Regular2Cleared 510(K)
- K222068Durex Penck III Regular2Cleared 510(K)
- K221906TROJAN Fire & Ice lubricated male natural rubber latex condom2Cleared 510(K)
- K220576FAMA Male Latex Condoms2Cleared 510(K)
- K221431TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant2Cleared 510(K)
- K211152Durex Condom with Benzocaine2Cleared 510(K)
- K213921Microthin Natural Rubber Latex Condom2Cleared 510(K)
- K213647Durex Patronus Wide2Cleared 510(K)
- K210208Titan Condoms2Cleared 510(K)
- K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla2Cleared 510(K)
- K211450Playboy 3 Contour Condom2Cleared 510(K)
- K210294One Touch Spiral Condom2Cleared 510(K)
- K203536Male Latex Condom2Cleared 510(K)
- K202403SKORE (Colors & Flavors), SKORE (Colors)2Cleared 510(K)
- K200672Durex Penck Standard, Durex Penck XL2Cleared 510(K)
- K193578Non-spermicidal Lubricated Male Latex Condom2Cleared 510(K)
- K201067CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))2Cleared 510(K)
- K192669Extremely Thin 003, ZERO ZERO THREE2Cleared 510(K)
- K181844One Touch2Cleared 510(K)
- K180104Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant2Cleared 510(K)
- K171213One Touch Condom with Benzocaine2Cleared 510(K)
- K172414JUD custom fit condom2Cleared 510(K)
- K162919Male Latex Condoms2Cleared 510(K)
- K163107Lifestyles Zero Lubricated Latex Male Condom2Cleared 510(K)
- K162511LELO RESPECT HEX Natural Rubber Latex Condom2Cleared 510(K)
- K153016aoni Natural Rubber Latex Condom2Cleared 510(K)
- K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant2Cleared 510(K)
- K161545Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant2Cleared 510(K)
- K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)2Cleared 510(K)
- K160644Lelo Hex Natural Rubber Latex Condom2Cleared 510(K)
- K150828O-RING Condom2Cleared 510(K)
- K150857Banana Gold2Cleared 510(K)
- K150072TheyFit Male Condom2Cleared 510(K)
- K132490SKORE AND MULTIPLE BRANDS2Cleared 510(K)
- K141059NATURAL RUBBER LATEX MALE CONDOMS2Cleared 510(K)
- K141256OKAMOTO STUDDED CONDOM2Cleared 510(K)
- K140379MEGA BIG BOY CONDOM2Cleared 510(K)
- K131866SUSTAIN2Cleared 510(K)
- K132390INSTINCT; PLAIN, DOTTED, ULTRA THIN2Cleared 510(K)
- K132107MALE LATEX CONDOM2Cleared 510(K)
- K132597BLACK COLOURED CONDOM2Cleared 510(K)
- K131887TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT2Cleared 510(K)
- K122219THEYFIT MALE CONDOM2Cleared 510(K)
- K121241MALE LATEX CONDOM2Cleared 510(K)
- K120555LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)2Cleared 510(K)
- K113056ORANGE COLORED CONDOMS ORANGE SCENT2Cleared 510(K)
- K120286TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT2Cleared 510(K)
- K120287TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT2Cleared 510(K)
- K120249TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT2Cleared 510(K)
- K120394LIFESTYLES ZERO LUBRICATED LATEX CONDOM2Cleared 510(K)
- K113686KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED2Cleared 510(K)
- K113061LARGE/EXTRA LAGRE CONDOM2Cleared 510(K)
- K111093BILLY BOY MALE LATEX CONDOM2Cleared 510(K)
- K103119BILLY BOY MALE LATEX CONDOM2Cleared 510(K)
- K092586MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU2Cleared 510(K)
- K081265THAI NIPPON MALE LATEX CONDOM2Cleared 510(K)
- K083817M. DIOR BRAND2Cleared 510(K)
- K082529ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM2Cleared 510(K)
- K090259OKAMOTO ULTRA THIN2Cleared 510(K)
- K081886KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED2Cleared 510(K)
- K081413TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K080833LOVE GUARD MALE LATEX CONDOM2Cleared 510(K)
- K070511RICHTER MALE LATEX CONDOM2Cleared 510(K)
- K072747UNIDUS MAGNUM MALE LATEX CONDOM2Cleared 510(K)
- K073016TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT2Cleared 510(K)
- K071313TROJAN-ENZ BRAND2Cleared 510(K)
- K070937MULTIPLE BRAND MALE LATEX CONDOM2Cleared 510(K)
- K071272TROJAN THINTENSITY BRAND MALE LATEX CONDOM2Cleared 510(K)
- K070830MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)2Cleared 510(K)
- K063401BANANA RIBBED2Cleared 510(K)
- K062730NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS2Cleared 510(K)
- K052206ZEUS MALE CONDOM APPLICATOR2Cleared 510(K)
- K051842GREEN LOVE MALE CONTRACEPTIVE (CONDOM)2Cleared 510(K)
- K060797NAKED2Cleared 510(K)
- K050913DICK'S FORMALWEAR MALE LATEX CONDOM2Cleared 510(K)
- K053367MALE NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K051288VIELLE LUBRICANT2Cleared 510(K)
- K052959DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS2Cleared 510(K)
- K051273DIVAS DUAL PLEASURE MALE LATEX CONDOM2Cleared 510(K)
- K050244MALE NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K042470DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM2Cleared 510(K)
- K050360TULIP CONDOM2Cleared 510(K)
- K042957DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT2Cleared 510(K)
- K041717POWERSTICK MALE LATEX CONDOMS2Cleared 510(K)
- K041667SAN-MAR LABS LUBRICATING JELLY2Cleared 510(K)
- K041432ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT2Cleared 510(K)
- K041837INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED2Cleared 510(K)
- K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM2Cleared 510(K)
- K040085PERSONAL WARMING LUBRICANT2Cleared 510(K)
- K032227DUREX FLAVORED LATEX CONDOM2Cleared 510(K)
- K032124DUREX PLAY LUBRICANT2Cleared 510(K)
- K033541LONG LOVE CONDOM2Cleared 510(K)
- K033076LIFESTYLES LIQUID PERSONAL LUBRICANT2Cleared 510(K)
- K032909THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM2Cleared 510(K)
- K031007KWIKEZE MALE CONDOM APPLICATOR2Cleared 510(K)
- K031369MERCATOR HEALTHCARE MALE LATEX CONDOM2Cleared 510(K)
- K023333MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR2Cleared 510(K)
- K030176LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT2Cleared 510(K)
- K022614INVIGRA2Cleared 510(K)
- K024324LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-92Cleared 510(K)
- K023128NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM2Cleared 510(K)
- K023405TROJAN MINT TINGLE BRAND LATEX CONDOMS2Cleared 510(K)
- K023176UNDUS MALE LATEX CONDOM (WITH FLAVORING)2Cleared 510(K)
- K023175UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)2Cleared 510(K)
- K023129UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)2Cleared 510(K)
- K023059UNIDUS MALE LATEX CONDOM2Cleared 510(K)
- K021186CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,2Cleared 510(K)
- K021125SENSUA!2Cleared 510(K)
- K021875MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM2Cleared 510(K)
- K020633NATURAL AND COLORED LATEX CONDOM WITH FLAVORS2Cleared 510(K)
- K020272MALE LATEX CONDOM WITH RIBBED SURFACE2Cleared 510(K)
- K020659DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT2Cleared 510(K)
- K011363JOE LUBE CONDOM2Cleared 510(K)
- K011378JOE LUB HELMET CONDOM2Cleared 510(K)
- K020223INVIGRA2Cleared 510(K)
- K013773SAFE2Cleared 510(K)
- K013086WET LIGHT PERSONAL MOISTURIZER2Cleared 510(K)
- K012962DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K01296456MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K012665ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT2Cleared 510(K)
- K012664ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT2Cleared 510(K)
- K012653MALE LATEX CONDOM2Cleared 510(K)
- K011253FLAVORED MALE LATEX CONDOM2Cleared 510(K)
- K010919MALE NATURAL RUBBER LATEX CONDOM2Cleared 510(K)
- K011480VIVA2Cleared 510(K)
- K010371LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT2Cleared 510(K)
- K010028SHEER THIN AROMAS RED LATEX CONDOM2Cleared 510(K)
- K004051SHEER THIN AROMAS YELLOW LATEX CONDOM2Cleared 510(K)
- K004036SHEER THIN AROMAS GREEN LATEX CONDOM2Cleared 510(K)
- K004016SHEER THIN AROMAS BLUE LATEX CONDOM2Cleared 510(K)
- K002393NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM2Cleared 510(K)
- K002571MULITPLE MALE LATX CONDOM2Cleared 510(K)
- K002060NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL2Cleared 510(K)
- K993389REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT2Cleared 510(K)
- K993409REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT2Cleared 510(K)
- K993403REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT2Cleared 510(K)
- K994118OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS2Cleared 510(K)
- K001883LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM2Cleared 510(K)
- K001221MALE LATEX COMDOM WITH DOTTED SURFACE2Cleared 510(K)
- K001212TROJAN EXTRA LARGE LATEX CONDOM2Cleared 510(K)
- K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM2Cleared 510(K)
- K000748TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT2Cleared 510(K)
- K000040INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED2Cleared 510(K)
- K000038INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED2Cleared 510(K)
- K000039INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED2Cleared 510(K)
- K994312MALE LATEX CONDOM 56MM2Cleared 510(K)
- K994311MALE LATEX CONDOM WITH VANILLA FLAVOR2Cleared 510(K)
- K993733LOVE LOCKERS2Cleared 510(K)
- K993737MIGHTY MAN (DYNAMIC LINKERS)2Cleared 510(K)
- K993735DOUBLE SPRINGERS2Cleared 510(K)
- K993405REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT2Cleared 510(K)
- K993404REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT2Cleared 510(K)
- K993395REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT2Cleared 510(K)
- K993408REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT2Cleared 510(K)
- K993396REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT2Cleared 510(K)
- K993390REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT2Cleared 510(K)
- K993779SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED2Cleared 510(K)
- K993782SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)2Cleared 510(K)
- K993781SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED2Cleared 510(K)
- K994095LATEX CONDOM2Cleared 510(K)
- K993693INVIGRA2Cleared 510(K)
- K993887ALATECH LATEX CONDOM2Cleared 510(K)
- K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL2Cleared 510(K)
- K991892TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR2Cleared 510(K)
- K984392ANSELL CONDOMS2Cleared 510(K)
- K990597SUMMER'S EVE LUBRICATING JELLY2Cleared 510(K)
- K983518LIFESTYLES XTRA PLEASURE2Cleared 510(K)
- K990925MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)2Cleared 510(K)
- K991374INVIGRA2Cleared 510(K)
- K991049CLIMAX2Cleared 510(K)
- K983216CVS PERSONAL LUBRICANT2Cleared 510(K)
- K980964MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS2Cleared 510(K)
- K982380SURE2Cleared 510(K)
- K984488SHEER THIN2Cleared 510(K)
- K984218OASIS2Cleared 510(K)
- K983320ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS2Cleared 510(K)
- K983380DUREX LUBRAGEL LATEX CONDOM2Cleared 510(K)
- K982924DUREX SENSIDOM LATEX CONDOM2Cleared 510(K)
- K982673JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM2Cleared 510(K)
- K980174DUREX COLORS AND SCENTS2Cleared 510(K)
- K980319DUREX ULTRA COMFORT2Cleared 510(K)
- K980204DUREX LATEX CONDOMS2Cleared 510(K)
- K980019HTL MALE CONDOM2Cleared 510(K)
- K971028WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED2Cleared 510(K)
- K974323LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT2Cleared 510(K)
- K973780PERSONAL LUBRICATING LIQUID2Cleared 510(K)
- K971793VERY PRIVATE INTIMATE MOISTURE2Cleared 510(K)
- K960552KNIGHT LIGHT NONLUBRICATED CONDOM2Cleared 510(K)
- K971132ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS2Cleared 510(K)
- K970581CLINIJEL2Cleared 510(K)
- K972428EXTRAWEAR, GENTLEMEN'S CHOICE2Cleared 510(K)
- K972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK2Cleared 510(K)
- K970792INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE2Cleared 510(K)
- K970767CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH2Cleared 510(K)
- K970633TUSTEX FLAVORED CONDOMS2Cleared 510(K)
- K964599TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR2Cleared 510(K)
- K964598TRUSTEX COLA FLAVORD CONDOM2Cleared 510(K)
- K964591TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR2Cleared 510(K)
- K955183SAFE KNIGHTS2Cleared 510(K)
- K963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN2Cleared 510(K)
- K963319OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN2Cleared 510(K)
- K963679LOVING SMARTER - SAFER SEX2Cleared 510(K)
- K960710CONDOM2Cleared 510(K)
- K946103TRUSTEX FLAVOR CONDON IN COLORS2Cleared 510(K)
- K955648K-Y PERSONAL LUBRICANT2Cleared 510(K)
- K945145RIA LATEX CONDOM, NONOXYNOL-92Cleared 510(K)
- K943880RIA LATEX CONDOM2Cleared 510(K)
- K953583LUBRICATED CONDOM2Cleared 510(K)
- K946207CONQUEROR, RUMBA AND TEMPTATION2Cleared 510(K)
- K954791SEMINAL FLUID COLLECTION KIT II2Cleared 510(K)
- K945930RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE2Cleared 510(K)
- K940047SPERMICIDALLY LUBRICATED CONDOM2Cleared 510(K)
- K944786RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)2Cleared 510(K)
- K941258LATEX CONDOM2Cleared 510(K)
- K952464PROBE PERSONAL LUBRICANT - CLASSIC2Cleared 510(K)
- K952465PROBE PERSONAL LUBRICANT - SILKY LIGHT2Cleared 510(K)
- K946374KIMONO MICROTHIN2Cleared 510(K)
- K946376MAXX2Cleared 510(K)
- K943064KIMONO (CONDOMS)2Cleared 510(K)
- K945246PREVENTOR AND PROTECTOR LATEX CONDOMS2Cleared 510(K)
- K952393OKAMOTO CONDOM2Cleared 510(K)
- K943933SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM2Cleared 510(K)
- K932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI2Cleared 510(K)
- K942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)2Cleared 510(K)
- K943883SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM2Cleared 510(K)
- K940046NON-LUBRICATED CONDOM2Cleared 510(K)
- K940045CONDOM2Cleared 510(K)
- K941831LUBRICATING JELLY2Cleared 510(K)
- K911431TACTYLON(TM) CONDOM2Cleared 510(K)
- K931077LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE2Cleared 510(K)
- K933153PENTHOUSE CONDOMS2Cleared 510(K)
- K932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)2Cleared 510(K)
- K932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)2Cleared 510(K)
- K932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI2Cleared 510(K)
- K920514SPIRAL2Cleared 510(K)
- K922889CONDOOM SHELF LIFE -- MODIFICATIONS2Cleared 510(K)
- K912405LATEX PROPHYLACTIC (CONDOM)2Cleared 510(K)
- K913813JIFFI CONDOM (RUBBER) CONTRACEPTIVE2Cleared 510(K)
- K912901TROJAN (TM-TBD) CONDOM2Cleared 510(K)
- K910470CONDOMS, MOODS/SHARE & RAKSHAK2Cleared 510(K)
- K902772PLEASURE PLUS2Cleared 510(K)
- K910284CONDOMS (RUBBER CONTRACEPTIVES)2Cleared 510(K)
- K910550CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW2Cleared 510(K)
- K910788CMI TENDER TOUCH VE #303TT AND 404TT2Cleared 510(K)
- K910578MCLAUGHLIN LAPAROSCOPIC GRASPER2Cleared 510(K)
- K902324TP AND DESIGN, CONDOM2Cleared 510(K)
- K902305TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.2Cleared 510(K)
- K902936POLYURETHANE CONDOM2Cleared 510(K)
- K905279CONDOM (RUBBER) CONTRACEPTIVE2Cleared 510(K)
- K904000TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR2Cleared 510(K)
- K905854CONDOMS2Cleared 510(K)
- K902907MAMBA CONDOM (RUBBER LATEX)2Cleared 510(K)
- K896098GUARDIAN & JANITEX CONDOM/PROPHYLACTIC2Cleared 510(K)
- K904375KIMONO PLUS2Cleared 510(K)
- K904453LABELLING MODIFICATION TO MAXX PLUS2Cleared 510(K)
- K904840ORION PLUS/MODIFICATION2Cleared 510(K)
- K902804EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT2Cleared 510(K)
- K902509SAXON RIBBED CONDOMS2Cleared 510(K)
- K897140THIN CONDOM RAMSES & SHEIK2Cleared 510(K)
- K896107RUBBER CONTRACEPTIVE2Cleared 510(K)
- K901202TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED2Cleared 510(K)
- K900679MINT SCENTED CONDOMS2Cleared 510(K)
- K896987RUBBER CONDOM (NON-COLORED)2Cleared 510(K)
- K896142RUBBER CONTRACEPTIVE (CONDOM)2Cleared 510(K)
- K901416CONDOM (RUBBER) CONTRACEPTIVE2Cleared 510(K)
- K901696LATEX CONDOMS - CODE NO. 403, 406, 421 & 10332Cleared 510(K)
- K901669LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 10002Cleared 510(K)
- K901668LATEX CONDOMS - CODE NO. 402, CODE NO. 10282Cleared 510(K)
- K901667LATEX CONDOMS - CODE NO. 401, 421 & 10022Cleared 510(K)
- K897129CONDOMS (MULTIPLE BRANDS)2Cleared 510(K)
- K893039CONDOM (RUBBER) CONTRACEPTIVE2Cleared 510(K)
- K901201TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED2Cleared 510(K)
- K901199TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED2Cleared 510(K)
- K901198TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED2Cleared 510(K)
- K901197TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL2Cleared 510(K)
- K901196TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING2Cleared 510(K)
- K901195TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED2Cleared 510(K)
- K901194TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL2Cleared 510(K)
- K901193TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)2Cleared 510(K)
- K901192TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)2Cleared 510(K)
- K901191TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)2Cleared 510(K)
- K901190TROJANS LATEX CONDOMS (MODIFIED LABELING)2Cleared 510(K)
- K901200TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED2Cleared 510(K)
- K900357GOLD CIRCLE COIN2Cleared 510(K)
- K900360SAXON ULTRA THIN2Cleared 510(K)
- K900359EMBRACE2Cleared 510(K)
- K900358SAXON WET LUBE2Cleared 510(K)
- K901112G.S.A. COLORED CONDOMS2Cleared 510(K)
- K901111NUDA (CURRENTLY CALLED ULTRA SENSITIVE)2Cleared 510(K)
- K896623SAFECON CONDOMS - PINK COLOR2Cleared 510(K)
- K895640MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT2Cleared 510(K)
- K895091RIA (CONDOM)2Cleared 510(K)
- K896339MODIFIED LABELING ON OKAMOTO HARMONY CONDOM2Cleared 510(K)
- K893217LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE2Cleared 510(K)
- K894533CONDOM (RUBBER LATEX) KILROY2Cleared 510(K)
- K895894PROFIL CONDOM (RUBBER LATEX)2Cleared 510(K)
- K895028BIRDS'N BEES CONDOMS2Cleared 510(K)
- K894534CONDOM (RUBBER LATEX) OKEIDO2Cleared 510(K)
- K895530STANDARD CONDOM2Cleared 510(K)
- K884692THE SAFEGARD PERSONAL PROTECTION KIT2Cleared 510(K)
- K880819CONDOMS2Cleared 510(K)
- K884925THE GREAT WALL CONDOM2Cleared 510(K)
- K890819HSV-CHECK(TM) TEST KIT2Cleared 510(K)
- K890407THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION2Cleared 510(K)
- K884454SAFECON CONDOMS - RIBBED2Cleared 510(K)
- K890863TROJAN FOR WOMEN2Cleared 510(K)
- K884470KIMONO PLUS OTHERS (MULTIPLE) CONDOMS2Cleared 510(K)
- K884468SUPER MAXX OTHERS (MULTIPLE) CONDOMS2Cleared 510(K)
- K884469ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS2Cleared 510(K)
- K883524SAFECON CONDOMS W/SPERMICIDAL LUBRICANT2Cleared 510(K)
- K883409AEGIS(TM) CONDOMS2Cleared 510(K)
- K884402EXTRA STRENGTH SKIN LESS SKIN CONDOM2Cleared 510(K)
- K884399STANDARD LATEX CONDOM2Cleared 510(K)
- K871358SENSATIONS BRAND CONDOMS2Cleared 510(K)
- K884401SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT2Cleared 510(K)
- K883413TROJAN EXTRA STRENGTH LUBRICATED2Cleared 510(K)
- K883467THE SAXON SPERMICIDAL CONDOM2Cleared 510(K)
- K882893CONDOMS (RAMSES, SHEIK AND KOROMEX)2Cleared 510(K)
- K882389KISS OF MINT(TM) NON-LUBRICATED CONDOM2Cleared 510(K)
- K882009KING KONDOM (CONDOM)2Cleared 510(K)
- K881100CONDOM2Cleared 510(K)
- K881735CONDOM2Cleared 510(K)
- K874236APOLLO CONDOM2Cleared 510(K)
- K880919(CHOICE) ALSO (KONDUM)2Cleared 510(K)
- K880189NEW JELLIACOAT2Cleared 510(K)
- K880820OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED2Cleared 510(K)
- K880185DUET (CONDOMS)2Cleared 510(K)
- K880463CONDOM (PROPHYLACTIC)2Cleared 510(K)
- K874921HEADFIRST (CONDOM)2Cleared 510(K)
- K875068AIDS SAFETY BELT2Cleared 510(K)
- K874791CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)2Cleared 510(K)
- K871267BLAUSIEGEL TRANSPARENT CONDOMS2Cleared 510(K)
- K874399SAFECON CONDOMS2Cleared 510(K)
- K872356CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)2Cleared 510(K)
- K871744CONTATTO CONDOMS2Cleared 510(K)
- K874383MENTOR PLUS (CONDOM)2Cleared 510(K)
- K880202OKAMOTO CONDOMS2Cleared 510(K)
- K875111RUBBER CONTRACEPTIVE, LATEX CONDOMS2Cleared 510(K)
- K874851XL-4 PAGODA (CONDOMS)2Cleared 510(K)
- K874135CONDOM (PROPHYLACTIC)2Cleared 510(K)
- K872861LOVIEL CONDOM2Cleared 510(K)
- K874718STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)2Cleared 510(K)
- K872799KIMONO (CONDOMS)2Cleared 510(K)
- K871451BESTCON/SPERMICIDE2Cleared 510(K)
- K874464SPERMICIDAL CONDOM2Cleared 510(K)
- K872504LUBRICATED CONDOM2Cleared 510(K)
- K872812SKINLESS-SKIN, PINK TINT (CONDOM)2Cleared 510(K)
- K872664SKINLESS SKIN-HARMONY CONDOMS2Cleared 510(K)
- K872619PREVENTETTE (CONDOM)2Cleared 510(K)
- K872005MAXIMUM, LATEX PROPHYLACTIC BRAND2Cleared 510(K)
- K872736PROPHYLACTIC (CONDOM)2Cleared 510(K)
- K871948ANGEL LATEX PROPHYLACTICS (CONDOMS)2Cleared 510(K)
- K871036CONDOM TAKASO RUBBER PRODUCTS SDN/BDH2Cleared 510(K)
- K871470BESTCON/LUBRICATED CONDOMS2Cleared 510(K)
- K871020KANGLE CONDOM2Cleared 510(K)
- K871304LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-92Cleared 510(K)
- K871300VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA2Cleared 510(K)
- K865106PROPHYLACTIC (CONDOM) MR. JOHNNY2Cleared 510(K)
- K862401PERSONAL/DERBY CONDOMS2Cleared 510(K)
- K864400EXTRA STRONG CONDOM2Cleared 510(K)
- K864570PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME2Cleared 510(K)
- K864482CHOICE2Cleared 510(K)
- K864473SEMINAL FLUID COLLECTION KIT(TM)2Cleared 510(K)
- K863190CHOICE CONDOM2Cleared 510(K)
- K863706LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-502Cleared 510(K)
- K863707LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-402Cleared 510(K)
- K860680PROTEX, TAHITI CONDOM2Cleared 510(K)
- K860909WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)2Cleared 510(K)
- K854622PROPHYLACTIC (CONDOM)2Cleared 510(K)
- K854247JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS2Cleared 510(K)
- K852620SAFE.N.SURE2Cleared 510(K)
- K851292LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-202Cleared 510(K)
- K851291LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-302Cleared 510(K)
- K851290LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-102Cleared 510(K)
- K841600CASABLANCA2Cleared 510(K)
- K842502WRINKLE CHAPEAU BLACKY2Cleared 510(K)
- K833365ULTRA SHAPE CONDOMS2Cleared 510(K)
- K842185PROTEX CONTRACEPT PLUS W/SPERM-LUB2Cleared 510(K)
- K834591STOPEX-CONDOMS-2Cleared 510(K)
- K833765TROJAN PLUS II2Cleared 510(K)
- K831816PROTEX CONTRACEPT PLUS W/SPERM-LUB2Cleared 510(K)
- K830691PRIME2Cleared 510(K)
- K823937SEMINAL COLLECTION DEVICE2Cleared 510(K)
- K822088MALE CONDOM2Cleared 510(K)
- K822792NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT2Cleared 510(K)
- K820564WORLD'S BEST (CONTRACEPTIVE)2Cleared 510(K)
- K813172CONDOM-MULTIPAL STYLES2Cleared 510(K)
- K800518UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,2Cleared 510(K)
- K792634CONCEPTROL/THIN PROPHYLACTICS2Cleared 510(K)
- K790433NATURDOM2Cleared 510(K)
- K772181PROPHYLACTIC2Cleared 510(K)
- K770412PROPHALACTICS2Cleared 510(K)
- KNDHeater, Perineal2Product Code
- KNESet, Anesthesia, Obstetric2Product Code
- KNHLaparoscopic Contraceptive Tubal Occlusion Device3Product Code
- KXQVibrator For Therapeutic Use, Genital2Product Code
- LTZCondom With Nonoxynol-92Product Code
- LZLMicro-Condom3Product Code
- MBUSingle-Use Internal Condom2Product Code
- MFDCannula, Intrauterine Insemination2Product Code
- NURPad, Interlabial1Product Code
- MOLCondom, Synthetic2Product Code
- MSCBarrier, Std, Oral Sex2Product Code
- NBVDevice, Engorgement, Clitoral2Product Code
- NRCPads, Menstrual, Scented-Deodorized1Product Code
- NUCLubricant, Personal2Product Code
- NUQPad, Menstrual, Reusable1Product Code
- OBBKit, Conception-Assist, Home Use2Product Code
- OBYCondom, Female, Animal Tissue3Product Code
- PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible2Product Code
- OHHBreast Pump Kit2Product Code
- OKWSeminal Fluid Collection Kit2Product Code
- OOAHemorrhoid Prevention Pressure Wedge2Product Code
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PAIMesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed3Product Code
- PNUPressure Wedge, Perianal, For Reduction Of Cesarean Delivery2Product Code
- PVTMaternity Kit1Product Code
- PVUObstetrical Anesthesia Kit2Product Code
- PVVParacervical Anesthesia Kit2Product Code
- PVWPudendal Anesthesia Kit2Product Code
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure1Product Code
- PYTDevice, Fertility Diagnostic, Contraceptive, Software Application2Product Code
- QPDPersonal Lubricant Ring2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Lelo Hex Natural Rubber Latex Condom
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160644
- 510(k) Type
- Traditional
- Applicant
- LELO Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/30/2016
- Days to Decision
- 115 days
- Submission Type
- Statement