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
- 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
- K242958Joylux Intimacy Gel (PG3100)2Cleared 510(K)
- K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)2Cleared 510(K)
- K242645INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant2Cleared 510(K)
- K240745ID Free Personal Lubricant2Cleared 510(K)
- K242162Coconut Hybrid2Cleared 510(K)
- K240081Human Lubricant2Cleared 510(K)
- K234099Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant2Cleared 510(K)
- K232040Gynatrof2Cleared 510(K)
- K231794Elegant™ Advanced CompHort2Cleared 510(K)
- K232093Woo More Play Coconut Love Oil2Cleared 510(K)
- K232091JO Coconut Hybrid Cooling Personal Lubricant2Cleared 510(K)
- K232090JO Coconut Hybrid Warming Personal Lubricant2Cleared 510(K)
- K223519Carex Hybrid Personal Lubricant2Cleared 510(K)
- K221137Play and Joy Water-Based Lubricant2Cleared 510(K)
- K220646Play&Joy InvisiLube Lubricant Capsule2Cleared 510(K)
- K230518HydraDose Vaginal Suppositories2Cleared 510(K)
- K230781Belle Sensilube2Cleared 510(K)
- K230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 401142Cleared 510(K)
- K220226X-Y Lubricating Jelly2Cleared 510(K)
- K213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine2Cleared 510(K)
- K222567Playground For All Love Sesh2Cleared 510(K)
- K222175Bloomi Delight Oil-Based Personal Lubricant2Cleared 510(K)
- K220273Onetouch Non-paraben Lubricant Gel2Cleared 510(K)
- K221243OFNat Lubricant (L15)2Cleared 510(K)
- K221829Wet Flavored Personal Lubricants2Cleared 510(K)
- K221908JO CUMPLAY Personal Lubricant2Cleared 510(K)
- K221328Bloomi Smooth Water Based Lubricant2Cleared 510(K)
- K220534Wet Essential95 Personal Lubricant2Cleared 510(K)
- K221036Astroglide Warming2Cleared 510(K)
- K213220Revaree Plus Vaginal Suppositories2Cleared 510(K)
- K220355Astroglide Ultra Gentle Gel2Cleared 510(K)
- K220653Astroglide Glycerin & Paraben Free2Cleared 510(K)
- K212260Sensuva Premium Silicone Personal Lubricant2Cleared 510(K)
- K213671Astroglide Sensual Strawberry Personal Lubricant2Cleared 510(K)
- K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry2Cleared 510(K)
- K210095Playboy Premium Silicone Lubricant2Cleared 510(K)
- K212104Water-soluble Personal Lubricant2Cleared 510(K)
- K212000Medley2Cleared 510(K)
- K211998Desnuda Reflect2Cleared 510(K)
- K211967Sensual Massage, Ultra Pure2Cleared 510(K)
- K210857Personal Lubricant2Cleared 510(K)
- K201612Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 52Cleared 510(K)
- K211088Grosz Play Feel2Cleared 510(K)
- K210814Coconu Water Based Personal Lubricant2Cleared 510(K)
- K203818Replens Long-Lasting Vaginal Moisturizer2Cleared 510(K)
- K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit2Cleared 510(K)
- K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two2Cleared 510(K)
- K202667Personal Lubricant Jelly2Cleared 510(K)
- K210242Astroglide X Silicone Personal Lubricant2Cleared 510(K)
- K203654Solevy Co. LLC Water-Based Personal Lubricant2Cleared 510(K)
- K203644Solevy Co. LLC Silicone Based Personal Lubricant2Cleared 510(K)
- K200527pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur2Cleared 510(K)
- K200731pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B52Cleared 510(K)
- K201922Trophikos Vaginal Moisturizer2Cleared 510(K)
- K202017Passion Natural Water Based Lubricant2Cleared 510(K)
- K203257LUBi Water Based Personal Lubricant2Cleared 510(K)
- K200730pjur WOMAN Nude pjur med SENSITIVE glide2Cleared 510(K)
- K193444Vagisan MoistCream Cremolum2Cleared 510(K)
- K200239Astroglide Organix Gel2Cleared 510(K)
- K200098VagiVital Aktivgel2Cleared 510(K)
- K200114Astroglide Organix Liquid2Cleared 510(K)
- K201186KY Grosz Jelly2Cleared 510(K)
- K200894Agape Cooling Personal Lubricant2Cleared 510(K)
- K200602Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant2Cleared 510(K)
- K192779Bunny Wax Personal Lubricant2Cleared 510(K)
- K200457Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming2Cleared 510(K)
- K200208Agape Warming Personal Lubricant2Cleared 510(K)
- K193032KY Grosz Liquid2Cleared 510(K)
- K192982KY Grosz UltraGel2Cleared 510(K)
- K191654SILICONE Personal Lubricant2Cleared 510(K)
- K193448BioNourish Lubricant2Cleared 510(K)
- K192203JO for Him H2O Gel Original Personal Lubricant2Cleared 510(K)
- K191411Ah!Yes Ob Coco Personal Lubricant2Cleared 510(K)
- K191052HyaloGYN Vaginal Moisturizing Suppositories2Cleared 510(K)
- K190752Satisfaite2Cleared 510(K)
- K192204Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,2Cleared 510(K)
- K191480Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)2Cleared 510(K)
- K190323Aloe Glide Lubricant2Cleared 510(K)
- K190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant2Cleared 510(K)
- K191214JO Premium Jelly Original Personal Lubricant2Cleared 510(K)
- K190150Sage 2-in-1 Personal Lubricant and Moisturizer2Cleared 510(K)
- K183050GLISSANT Intimate Lubricant2Cleared 510(K)
- K183505KY Banksy Moisture2Cleared 510(K)
- K182100Smile Makers Personal Lubricant2Cleared 510(K)
- K183584JO H2O Jelly Original Personal Lubricant2Cleared 510(K)
- K183302KY Banksy Aloe2Cleared 510(K)
- K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant2Cleared 510(K)
- K180014Creme de La Femme Feminine Lubricant2Cleared 510(K)
- K180828Natureplex Warm Touch Warming Jelly2Cleared 510(K)
- K182027Wet Organics Personal Lubricant2Cleared 510(K)
- K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant2Cleared 510(K)
- K181078The Sex Gel2Cleared 510(K)
- K181408JO Classic Hybrid Personal Lubricant2Cleared 510(K)
- K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)2Cleared 510(K)
- K180923Personal Lubricating Jelly2Cleared 510(K)
- K180712Coconut Infused Hybrid Personal Lubricant2Cleared 510(K)
- K180136BioNude Lubricant2Cleared 510(K)
- K180219JO H2O Flavored Personal Lubricants2Cleared 510(K)
- K172306SuperSlyde Personal Lubricant2Cleared 510(K)
- K180083Silicone Personal Lubricant, ALL-IN-ONE2Cleared 510(K)
- K171516Flip Lube2Cleared 510(K)
- K173504K-Y Silicone2Cleared 510(K)
- K172473LifeStyles® SKYN® Intimate Moments Personal Lubricant2Cleared 510(K)
- K170797wettrust D2care2Cleared 510(K)
- K171044Climax Personal Lubricant2Cleared 510(K)
- K172447JO Gelato Flavored Personal Lubricants2Cleared 510(K)
- K163674Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry2Cleared 510(K)
- K171730FuckWater2Cleared 510(K)
- K171985Astroglide O Oil Personal Lubricant & Massage Oil2Cleared 510(K)
- K171855External Moisturizing Gel2Cleared 510(K)
- K171021JO Agapé Personal Lubricant2Cleared 510(K)
- K162569YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer2Cleared 510(K)
- K162207Restore Moisturizing Vaginal Lubricant2Cleared 510(K)
- K162235LUVENA VAGINAL MOISTURIZER & LUBRICANT2Cleared 510(K)
- K163395Astroglide Diamond Silicone Gel Personal Lubricant2Cleared 510(K)
- K151857Love Alchemy's Love Lotion2Cleared 510(K)
- K161585Mano and Mano Personal Lubricant2Cleared 510(K)
- K161544Trojan Chain Reaction Personal Lubricant2Cleared 510(K)
- K161385Just Like Me Personal Lubricant2Cleared 510(K)
- K152671Pulse Aloe-ahh2Cleared 510(K)
- K152628Pulse H20h!2Cleared 510(K)
- K153372Repagyn vaginal suppositories2Cleared 510(K)
- K160763ally Liquid Personal Lubricant2Cleared 510(K)
- K160717ally Warming Liquid Personal Lubricant2Cleared 510(K)
- K152918Gun Oil, Pink, Gun Oil H2O, Pink Water2Cleared 510(K)
- K152507Dr. Wolff Vagisan Moisturising Cream2Cleared 510(K)
- K160211Wet Original Personal Lubricant2Cleared 510(K)
- K152646SYLK PERSONAL LUBRICANT2Cleared 510(K)
- K152168Love Liquid Personal Lubricant2Cleared 510(K)
- K151884K-Y Marilyn Pleasure Gel2Cleared 510(K)
- K150841Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant2Cleared 510(K)
- K150094Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla2Cleared 510(K)
- K150743Water Based Personal Lubricant with Flavours2Cleared 510(K)
- K150397Divine 92Cleared 510(K)
- K150153Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant2Cleared 510(K)
- K151647Uberlube2Cleared 510(K)
- K143349Gynomunal2Cleared 510(K)
- K150883HyaloGYN Vaginal Hydrating Gel2Cleared 510(K)
- K143529UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer2Cleared 510(K)
- K143532Durex Silicone2Cleared 510(K)
- K142790OneTouch Lubricant Gel2Cleared 510(K)
- K142726O Glide Personal Lubricant2Cleared 510(K)
- K150886Trojan Riviera Personal Lubricant2Cleared 510(K)
- K143322Medline Natural Lubricating Liquid2Cleared 510(K)
- K150480JO H20 Water Based Personal Lubricant2Cleared 510(K)
- K143511K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant2Cleared 510(K)
- K150615Vaginal Moisturizing Gel2Cleared 510(K)
- K140506JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL2Cleared 510(K)
- K141913PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!2Cleared 510(K)
- K141767ID MILLENNIUM, ID MOMENTS SILICONE2Cleared 510(K)
- K150147Lubrigyn cream2Cleared 510(K)
- K131643DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT2Cleared 510(K)
- K141718INTERNAL HYDRATING GEL2Cleared 510(K)
- K140193DUREX EMBRACE PERSONAL LUBRICANT2Cleared 510(K)
- K140590ASTROGLIDE SENSUAL STRAWBERRY2Cleared 510(K)
- K140304SIMPLY SLICK PERSONAL LUBRICATING LOTION2Cleared 510(K)
- K132772LUBRIGYN CREAM2Cleared 510(K)
- K141581ASTROGLIDE NATURAL2Cleared 510(K)
- K133336PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE2Cleared 510(K)
- K141034AZUL PERSONAL LUBRICANT2Cleared 510(K)
- K133233PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE2Cleared 510(K)
- K132954JO PREMIUM PERSONAL LUBRICANT2Cleared 510(K)
- K122061K-Y BRAND LIQUIBEADS2Cleared 510(K)
- K131084SASMAR ORIGINAL, SASMAR CLASSIC2Cleared 510(K)
- K124044ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS2Cleared 510(K)
- K130012WET PLATINUM PERSONAL LUBRICANT2Cleared 510(K)
- K130345AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING2Cleared 510(K)
- K123427NIRVANA D PERSONAL LUBRICANT (TBD)2Cleared 510(K)
- K123770WARMING JELLY PERSONAL LUBRICANT2Cleared 510(K)
- K122476LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT2Cleared 510(K)
- K122720LIFESTYLES WARM LOVIN PERSONAL LUBRICANT2Cleared 510(K)
- K122477LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT2Cleared 510(K)
- K122054LIFESTYLES NATURAL PERSONAL LUBRICANT2Cleared 510(K)
- K112217ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER2Cleared 510(K)
- K120706NIRVANA A PERSONAL LUBRICANT2Cleared 510(K)
- K120751NIRVANA B PERSONAL LUBRICANT2Cleared 510(K)
- K120650POISE PERSONAL LUBRICANT2Cleared 510(K)
- K110690ONE PERSONAL LUBRICANT (SILICONE)2Cleared 510(K)
- K110691ONE PERSONAL LUBRICANT (WATER BASED)2Cleared 510(K)
- K110325AQUA LUBE2Cleared 510(K)
- K101585K-Y BRAND LONG LASTING VAGINAL MOISTURIZER2Cleared 510(K)
- K101241REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)2Cleared 510(K)
- K101098REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 830352Cleared 510(K)
- K094039HYALO GYN2Cleared 510(K)
- K091298LUBREASE FEMALE LUBRICANT2Cleared 510(K)
- K091554PHARMAPAC PERSONAL LUBRICANT2Cleared 510(K)
- K080978WALGREEN'S PERSONAL LUBRICATING JELLY2Cleared 510(K)
- K081236K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME2Cleared 510(K)
- K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT2Cleared 510(K)
- K070587ELEGANCE WOMAN'S LUBRICANT2Cleared 510(K)
- K071626DUREX PLAY SOFT & SENSUAL LUBRICANT2Cleared 510(K)
- K063385DUREX PLAY MASSAGE GEL LUBRICANT2Cleared 510(K)
- K072421K-Y BRAND YOURS+MINE2Cleared 510(K)
- K072647GLYCERIN & PARABEN FREE ASTROGLIDE2Cleared 510(K)
- K072360K-Y BRAND INTRIGUE INTENSE WARMING SENSATION2Cleared 510(K)
- K070623PHARMAPAC LUBRICATING JELLY2Cleared 510(K)
- K062682CVS PERSONAL LUBRICANT AND MOISTURIZER2Cleared 510(K)
- K070545K-Y BRAND WARMING LIQUID2Cleared 510(K)
- K062535K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING2Cleared 510(K)
- K062796K-Y BRAND INTRIGUE2Cleared 510(K)
- K061466INTIMOL2Cleared 510(K)
- K051688FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS2Cleared 510(K)
- K060098DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS2Cleared 510(K)
- K060145FDS INTIMATE AND INTIMATE WARMING LUBRICANT2Cleared 510(K)
- K053397K-Y BRAND SENSUAL MIST2Cleared 510(K)
- K051295I-D GLIDE2Cleared 510(K)
- K052162SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT2Cleared 510(K)
- K052974WARMING LIQUID PERSONAL LUBRICANT2Cleared 510(K)
- K042915O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT2Cleared 510(K)
- K040428MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM2Cleared 510(K)
- K051668THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT2Cleared 510(K)
- K042958DUREX PLAY TINGLING LUBRICANT2Cleared 510(K)
- K050212PERSONAL WARMING JELLY2Cleared 510(K)
- K050211PERSONAL WARMING GEL2Cleared 510(K)
- K041129PERSONAL LUBRICATING GEL2Cleared 510(K)
- K033776INSTEAD INTIMATE LUBRICANT2Cleared 510(K)
- K040340K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT2Cleared 510(K)
- K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANT2Cleared 510(K)
- K021737REPHRESH VAGINAL GEL2Cleared 510(K)
- K021492K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT2Cleared 510(K)
- K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANT2Cleared 510(K)
- K013433TROJAN PASSION BERRY GEL2Cleared 510(K)
- K013614TROJAN CRYSTAL CLEAR LIQUID2Cleared 510(K)
- K012203CLAY-PARK LABS, INC. - LUBRICATING JELLY2Cleared 510(K)
- K010199PJUR EROS WATER FORMULATION2Cleared 510(K)
- K010182VCF PERSONAL LUBRICANT2Cleared 510(K)
- K003867EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)2Cleared 510(K)
- K001077LUBRIGEL PERSONAL LUBRICANT2Cleared 510(K)
- 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
Bloomi Smooth Water Based Lubricant
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221328
- 510(k) Type
- Traditional
- Applicant
- The Bloomi Inc..
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/4/2022
- Days to Decision
- 90 days
- Submission Type
- Summary