Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 24
- Latest Decision
- 2001-09-14
Clearances · page 64 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K012526 | BIOTEQUE SCALP VEIN SET | Bioteque Corp. | FPA | Class II | 2001-09-14 |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | National Custom Ent., Inc. | MRZ | Class II | 2001-09-12 |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | National Custom Ent., Inc. | MRZ | Class II | 2001-09-12 |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | National Custom Ent., Inc. | MRZ | Class II | 2001-09-12 |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | Churchill Medical Systems, Inc. | FMG | Class II | 2001-09-11 |
| K011242 | HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE | Acusupply, Inc. | MQX | Class II | 2001-09-11 |
| K011045 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Shen Wei (Usa), Inc. | LYY | Class I | 2001-09-11 |
| K011407 | LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO | Sempermed USA, Inc. | LYY | Class I | 2001-09-11 |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC | National Custom Ent., Inc. | FMT | Class II | 2001-09-10 |
| K011888 | PRESSURE ACTIVATED CHECK VALVE | Churchill Medical Systems, Inc. | FPA | Class II | 2001-09-10 |
| K012902 | POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100; POLY PER-Q-CATH DUAL LUMEN PICC CATHETER, MODEL 3246100 | C.R. Bard, Inc. | LJS | Class II | 2001-09-10 |
| K011044 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER | Shen Wei (Usa), Inc. | LYY | Class I | 2001-09-10 |
| K012136 | AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER | Avita Corporation | FLL | Class II | 2001-09-10 |
| K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC | Getinge/Castle, Inc. | FLE | Class II | 2001-09-05 |
| K002394 | JMS APHERESIS NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | FMI | Class II | 2001-09-05 |
| K011868 | ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS | Debio Tech SA | LZH | Class II | 2001-09-04 |
| K010404 | EXEL I.V. ADMINISTRATION SET | Exelint Intl. Co. | FPA | Class II | 2001-08-30 |
| K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET | Becton, Dickinson & CO | FMI | Class II | 2001-08-29 |
| K003555 | SOLO-SAFE SAFETY SYRINGE, SIZE-3CC | Spectrum Biotech, Inc. | MEG | Class II | 2001-08-29 |
| K012044 | BI-PHASIC INFILTRATOR | Reliance Medical Corp. | FRN | Class II | 2001-08-28 |
| K011937 | TRULINE INFUSION CATHETERS | Micro Therapeutics, Inc. | FOZ | Class II | 2001-08-28 |
| K012646 | TERUMO 30 GAUGE HYPODERMIC NEEDLE | Terumo Medical Corp. | FMI | Class II | 2001-08-27 |
| K012754 | EZ SET INFUSION SET | Animas Corp. | FPA | Class II | 2001-08-27 |
| K011749 | LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS | Sempermed USA, Inc. | LYY | Class I | 2001-08-22 |
| K001853 | SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 | Medtech Systems, Inc. | FMI | Class II | 2001-08-22 |
| K012276 | TEMP 3 | Medical Solutions, Inc. | LGZ | Class II | 2001-08-20 |
| K011765 | SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE | Sunmax Enterprise Shanghai Co. , Ltd. | LZA | Class I | 2001-08-16 |
| K012048 | POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2001-08-16 |
| K011717 | SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES | Sunmax Enterprise Shanghai Co. , Ltd. | LZA | Class I | 2001-08-14 |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | Northgate Technologies, Inc. | FPA | Class II | 2001-08-10 |
| K011176 | REUSABLE GLASS SYRINGES | Lockett Medical Corp. | FMF | Class II | 2001-08-10 |
| K012330 | SIMPLICITY EURO QD INFUSION SET | Sterling Medivations, Inc. | FPA | Class II | 2001-08-10 |
| K012282 | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE | Cypress Medical Products, Ltd. | LYZ | Class I | 2001-08-06 |
| K010534 | CROSS-CHECKS DUAL, MODEL CI 125 | Steritec Products, Inc. | JOJ | Class II | 2001-08-06 |
| K011951 | EZ SYRINGE | Owen Mumford, Ltd. | FMF | Class II | 2001-08-02 |
| K011791 | POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR | Latexx Partners Bhd. | LZA | Class I | 2001-08-01 |
| K012217 | M5T INSTANT FEVER THERMOMETER | Medisim, Ltd. | FLL | Class II | 2001-08-01 |
| K012128 | PROTECTIV ACUVANCE IV CATHETER SYSTEM | Ethicon Endo-Surgery, Inc. | FOZ | Class II | 2001-08-01 |
| K011792 | NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | Latexx Partners Bhd. | LZA | Class I | 2001-08-01 |
| K003839 | CENTRAL VENOUS CATHETER | Boston Scientific Corp | LJS | Class II | 2001-08-01 |
| K012166 | NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) | Best Manufacturing Company | LZA | Class I | 2001-08-01 |
| K011995 | POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Quality Latex Products Malaysia Sdn Bhd | LYY | Class I | 2001-07-31 |
| K011549 | OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM | Ohmeda Medical | LBI | Class II | 2001-07-19 |
| K011216 | PVC FREE INTRAVASCULAR ADMINISTRATION SET | Biometrix , Ltd. | FPA | Class II | 2001-07-18 |
| K003966 | WUNDCATH CONDUCTION CATHETER | Micor, Inc. | FRN | Class II | 2001-07-17 |
| K011712 | LATEX EXAMINATION GLOVES- POWDER FREE, BLUE | Pt.Shamrock Manufacturing Corp. | LYY | Class I | 2001-07-17 |
| K011883 | POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | 2001-07-17 |
| K011982 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Bd | FOZ | Class II | 2001-07-17 |
| K011884 | POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | 2001-07-17 |
| K011885 | SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | 2001-07-16 |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | Primary Care Solutions, Inc. | JOL | Class II | 2001-07-12 |
| K011291 | TEMPORALSCANNER THERMOMETER, SENSORTOUCH | Exergen Corp. | FLL | Class II | 2001-07-12 |
| K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO | Sims Portex, Inc. | FMI | Class II | 2001-07-12 |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | JOL | Class II | 2001-07-12 |
| K011786 | VACUETTE SAFETY BLOOD COLLECTION SET | Greiner Vacuette North America, Inc. | FMI | Class II | 2001-07-12 |
| K010546 | POWDER FREE LATEX EXAMINATION GLOVES | Jb Star Sdn Bhd | LYY | Class I | 2001-07-10 |
| K011293 | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES | Multisafe Sdn. Bhd. | LYY | Class I | 2001-07-10 |
| K011808 | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) | Asia-Med GmbH and CO KG | MQX | Class II | 2001-07-10 |
| K011882 | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES | Shijiazhuang Eversharp Plastic Products Co., Ltd. | LYZ | Class I | 2001-07-10 |
| K011924 | POWDERED BLUE NITRILE EXAMINATION GLOVES | Seltom Pacific Sdn. Bhd. | LZA | Class I | 2001-07-10 |
| K011254 | EAR THERMOMETER, MODELS ST613C AND ST613F | Mesure Technology | FLL | Class II | 2001-07-10 |
| K011497 | CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE | Tillotson Healthcare Corp. | LZA | Class I | 2001-07-10 |
| K011895 | POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH | Pwa Industries Sdn. Bhd. | LYY | Class I | 2001-07-09 |
| K010235 | TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX | Oriental System Technology, Inc. | FLL | Class II | 2001-07-09 |
| K011117 | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS | Mps Acacia | MEB | Class II | 2001-07-09 |
| K011728 | BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( | Brightway Holdings Sdn. Bhd. | LYY | Class I | 2001-07-09 |
| K003254 | CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001 | Mission Medicl Devices | FPA | Class II | 2001-07-09 |
| K011669 | BW ACUPUNCTURE NEEDLES | H F Intl. Co. | MQX | Class II | 2001-07-09 |
| K011482 | DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2001-07-09 |
| K011922 | POWDERED LATEX EXAMINATION GLOVES | Seltom Pacific Sdn. Bhd. | LYY | Class I | 2001-07-05 |
| K011713 | SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE | Kimberly-Clark Corp. | LZA | Class I | 2001-07-05 |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | Spintech, Inc. | FMF | Class II | 2001-06-29 |
| K002409 | MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER | Automatic Medical Technologies, Inc. | LGZ | Class II | 2001-06-28 |
| K011317 | MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM | Baxter Healthcare Corp | MEB | Class II | 2001-06-28 |
| K011704 | NPAC EAR THERMOMETER MODEL TD 402 | Norm Pacific Automation Corp. | FLL | Class II | 2001-06-27 |
| K011860 | KEYST0NE MEDICAL PICC CATHETER | Keystone Medical | FOZ | Class II | 2001-06-27 |
| K010888 | SIDEPORT PINCH CLAMP DEVICE | Medivice Systems, Ltd. | FPA | Class II | 2001-06-27 |
| K010937 | SEP-10S PLUS, AND SP-12S PRO. | Viltechmeda | FRN | Class II | 2001-06-25 |
| K010703 | INTER-VIAL | Duoject Medical Systems, Inc. | LHI | Class II | 2001-06-25 |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Hydrocision, Inc. | FQH | Class II | 2001-06-22 |
| K010233 | POWDER FREE NITRILE EXAMINATION GLOVES | P.T. Healthcare Glovindo | LZA | Class I | 2001-06-22 |
| K011593 | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | Ansell Healthcare Products, Inc. | LZA | Class I | 2001-06-21 |
| K010406 | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G | Jms Co., Ltd. | FOZ | Class II | 2001-06-20 |
| K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET | Nipro Medical Corp. | FOZ | Class II | 2001-06-20 |
| K010410 | JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G | Jms Co., Ltd. | FOZ | Class II | 2001-06-20 |
| K011858 | INTERLINK THREADED LOCK CANNULA | Bd | FPA | Class II | 2001-06-19 |
| K011187 | SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS | Sterling Medivations, Inc. | FPA | Class II | 2001-06-19 |
| K011103 | BD SPRING BASED SYRINGE | Bd | MEG | Class II | 2001-06-13 |
| K010854 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) | Protection Gloves Sdn. Bhd. | LYY | Class I | 2001-06-13 |
| K002727 | YOUNG-HEALTH SUPER EAR THERMOMETER | Young Health Ind. Co., Ltd. | FLL | Class II | 2001-06-13 |
| K011231 | CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN | Protection Gloves Sdn. Bhd. | LYY | Class I | 2001-06-13 |
| K011585 | FAST THERMOMETER MODELS ST713C AND ST713F | Mesure Technology | FLL | Class II | 2001-06-13 |
| K001281 | GERATHERM BABYWATCH TEMPERATURE MONITOR | Geratherm AG | FLL | Class II | 2001-06-12 |
| K011193 | NAC PLUS NEEDLELESS ACCESS CONNECTOR | Porex Medical Products | FPA | Class II | 2001-06-12 |
| K003047 | AMBULATORY ENTERAL NUTRITION PUMP | Ross Product Div. Abbott Laboratories | LZH | Class II | 2001-06-12 |
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | Churchill Medical Systems, Inc. | FPA | Class II | 2001-06-12 |
| K010887 | INSULIN PEN NEEDLE ADAPTER | Ohana Needle Co. | FMI | Class II | 2001-06-08 |
| K010875 | HYCARE LATEX EXAMINATION GLOVE, POWDERED | Hycare Intl. Co., Ltd. | LYY | Class I | 2001-06-07 |
| K011370 | NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG | Sgmp Co., Ltd. | LYY | Class I | 2001-06-07 |
| K011371 | NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW | Sgmp Co., Ltd. | LYY | Class I | 2001-06-07 |
15,723 clearances in the General Hospital panel. Data: openFDA.