Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 32
- Latest Decision
- 2015-12-02
Clearances · page 27 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150787 | Universal Spike | B.Braun Medical, Inc. | LHI | Class II | 2015-12-02 |
| K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | FRC | Class II | 2015-12-01 |
| K151679 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Heze Yuze Glove Co., Ltd. | LYZ | Class I | 2015-11-27 |
| K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FOZ | Class II | 2015-11-23 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | LJT | Class II | 2015-11-20 |
| K150698 | Gemini Sterilization Wrap | Medline Industries, Inc. | FRG | Class II | 2015-11-20 |
| K150645 | AN1087 Dosimeter | Andersen Sterilizers, Inc. | JOJ | Class II | 2015-11-19 |
| K151585 | Andersen EOGas 4 SteriTest | Andersen Sterilizers, Inc. | FRC | Class II | 2015-11-18 |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | FLF | Class II | 2015-11-18 |
| K150644 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | JOJ | Class II | 2015-11-18 |
| K152058 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | FRG | Class II | 2015-11-18 |
| K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | FMI | Class II | 2015-11-18 |
| K151682 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Daxwell, LLC | LYZ | Class I | 2015-11-17 |
| K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) | Anhui Anyu Latex Products Co., Ltd. | LYY | Class I | 2015-11-16 |
| K143693 | MEDLINE SHARPS CONTAINERS | Medline Industries, Inc. | MMK | Class II | 2015-11-06 |
| K150219 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical , Ltd. | ONB | Class II | 2015-11-05 |
| K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | MEG | Class II | 2015-11-04 |
| K152183 | EXELINT SecureTouch Safety Hypodermic Needle | Exelint International, Co. | FMI | Class II | 2015-11-02 |
| K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | FRG | Class II | 2015-10-30 |
| K141854 | INSTRUMENT CASSETTE (EFCCL1-F) | Osung Mnd Co., Ltd. | KCT | Class II | 2015-10-29 |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products | FRC | Class II | 2015-10-29 |
| K143117 | Wire Sterilization Package with Indicators | American Orthodontics | FRG | Class II | 2015-10-29 |
| K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2015-10-21 |
| K152261 | PICC Tip Positioning Aid | Nostix, LLC | LJS | Class II | 2015-10-21 |
| K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | KCT | Class II | 2015-10-20 |
| K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring system | Medisim, Ltd. | FLL | Class II | 2015-10-20 |
| K151347 | MIS Spine Frame Instrument Case | Thompson Surgical Instruments | KCT | Class II | 2015-10-16 |
| K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | Terumo (Philippines) Corporation | FMI | Class II | 2015-10-16 |
| K151571 | Mini Needle | Ocujet, LLC | FMI | Class II | 2015-10-14 |
| K150687 | DripAssist | Shift Labs | FLN | Class II | 2015-10-13 |
| K151528 | Powder Free Nitrile (Black) Examination Gloves | Gallant Quality Sdn. Bhd. | LZA | Class I | 2015-10-09 |
| K151242 | SterilContainer S | Aesculap, Inc. | KCT | Class II | 2015-10-09 |
| K150694 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | JOJ | Class II | 2015-10-01 |
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | FPA | Class II | 2015-09-30 |
| K151777 | Intradermal Adapter | West Pharmaceutical Services, Inc. | FMF | Class II | 2015-09-29 |
| K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | JOJ | Class II | 2015-09-29 |
| K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | FPA | Class II | 2015-09-24 |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | Navilyst Medical, Inc. | LJS | Class II | 2015-09-24 |
| K151684 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2015-09-18 |
| K151208 | Powder Free Nitrile Examination Glove | Vrg Khai Hoan Joint Stock Company | LZA | Class I | 2015-09-14 |
| K143177 | KleenGel Dispenser | Kleengel, LLC | KYX | Class I | 2015-09-14 |
| K143637 | U&U Sterilization Pouch and Roll | U&U Medical Technology Co, Ltd. | FRG | Class II | 2015-09-09 |
| K151249 | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON | Pureway Compliance, Inc. | MMK | Class II | 2015-09-04 |
| K152208 | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | LGZ | Class II | 2015-09-02 |
| K151766 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | FMF | Class II | 2015-09-02 |
| K143267 | TempTraq TT-100 | Blue Spark Technologies, Inc. | FLL | Class II | 2015-09-02 |
| K150143 | Normal Saline Flush | Nurse Assist, Inc. | NGT | Class II | 2015-08-31 |
| K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | KCT | Class II | 2015-08-28 |
| K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | MQX | Class II | 2015-08-25 |
| K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2015-08-24 |
| K151341 | Turbo High-Flow Non-coring Needle | Norfolk Medical | FMI | Class II | 2015-08-20 |
| K143289 | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2015-08-18 |
| K143729 | SterilContainer S | Aesculap, Inc. | KCT | Class II | 2015-08-18 |
| K151166 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | KCT | Class II | 2015-08-18 |
| K143446 | Accu-Chek FlexLink Plus infusion set | Roche Diagnostics GmbH | FPA | Class II | 2015-08-13 |
| K143583 | Cathivex ¿GV filter units | Merck Millipore , Ltd. | FPB | Class II | 2015-08-11 |
| K142765 | TM SAFETY NEEDLE | Thinkmed Medical Technology Co., Ltd. | FMI | Class II | 2015-08-11 |
| K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | LHI | Class II | 2015-07-31 |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | FMF | Class II | 2015-07-31 |
| K143277 | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), | Lifestyle Safety Products (Hui Zhou) Co., Ltd. | LYZ | Class I | 2015-07-29 |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2015-07-27 |
| K143347 | Powder-Free Yellow Vinyl Patient Examination Gloves | Zibo Zhouheng Plastic Products Co., Ltd. | LYZ | Class I | 2015-07-24 |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | B.Braun Medical, Inc. | FPA | Class II | 2015-07-24 |
| K150486 | Halo | J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB | Class II | 2015-07-24 |
| K143346 | Powder-Free White Vinyl Patient Examination Gloves | Zibo Changda Plastic Products Company, Limited | LYZ | Class I | 2015-07-22 |
| K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | Maanshan Bond Medical Instruments Co., Ltd. | MQX | Class II | 2015-07-15 |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | FQH | Class II | 2015-07-15 |
| K150611 | MedSource ClearSafe Safety IV Catheter | Medsource International | FOZ | Class II | 2015-07-15 |
| K143340 | Powder Free Vinyl Patient Examination Gloves, Yellow Color | Zibo Ling Yun Medical Products Co, Ltd. | LYZ | Class I | 2015-07-09 |
| K150484 | Penguin In-Line Warmer | Creche Innovations | LGZ | Class II | 2015-07-09 |
| K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | FOZ | Class II | 2015-07-08 |
| K142970 | SterilContainer S System | Aesculap, Inc. | KCT | Class II | 2015-07-08 |
| K143070 | Disposable Safety Self-destructive Syringes, 5 ML | Jiangsu Yile Medical Article Co., Ltd. | MEG | Class II | 2015-07-07 |
| K151543 | Graft Delivery Device with Integrated Stylet | Micromedics, Inc. (D/B/A Nordson Medical) | FMF | Class II | 2015-07-07 |
| K150477 | 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization | 3M Company | JOJ | Class II | 2015-07-02 |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | OZW | Class II | 2015-06-27 |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | Terumo Europe N.V. | FMI | Class II | 2015-06-25 |
| K143437 | Droplet Pen Needles | Htl-Strefa S.A | FMI | Class II | 2015-06-25 |
| K150540 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | KCT | Class II | 2015-06-22 |
| K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | Hebei Hongsen Plastics Technology Co, Ltd. | LZA | Class I | 2015-06-18 |
| K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | FRN | Class II | 2015-06-18 |
| K142797 | I.V. Catheter | Jiangxi Sanxin Medtec Co., Ltd. | FOZ | Class II | 2015-06-18 |
| K150113 | Fusion Black Powder-Free Nitrile Exam Glove | Halyard Health | LZA | Class I | 2015-06-18 |
| K141879 | BELIMED STEAM STERILIZER MST-H | Sauter AG | FLE | Class II | 2015-06-17 |
| K150414 | Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL | Industrial Clothings (Pvt), Ltd. | LZA | Class I | 2015-06-12 |
| K142416 | Luma Wrap | Salter Labs | PDH | Class II | 2015-06-12 |
| K142920 | KM Needles (Acupuncture Needle) | K.M.S., Inc. | MQX | Class II | 2015-06-10 |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | Ypsomed AG | FMI | Class II | 2015-06-09 |
| K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) | Crosstex | JOJ | Class II | 2015-06-09 |
| K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2015-06-09 |
| K143715 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Better Plastic Co., Ltd. | LYZ | Class I | 2015-06-05 |
| K142518 | HumaPen Luxura | Eli Lilly and Company | FMF | Class II | 2015-06-05 |
| K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology | Arrow International (A Subsidiary of Teleflex, Inc.) | FOZ | Class II | 2015-06-05 |
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | MEG | Class II | 2015-06-02 |
| K142768 | Instru-Safe Instrument Protection System | Summit Medical, Inc. | KCT | Class II | 2015-05-29 |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | Covidien | LZH | Class II | 2015-05-29 |
| K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set | Imed Technology, Inc. | FPA | Class II | 2015-05-28 |
| K142806 | DualCap | Catheter Connections, Inc. | QBP | Class II | 2015-05-22 |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | LJT | Class II | 2015-05-21 |
| K143629 | U&U Bowie-Dick Test Pack | U&U Medical Technology Co, Ltd. | JOJ | Class II | 2015-05-19 |
15,723 clearances in the General Hospital panel. Data: openFDA.