Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 34
- Latest Decision
- 2023-12-22
Clearances · page 6 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233264 | Anthogyr INTEGRAL Guided Surgery Cassettes | Anthogyr | KCT | Class II | 2023-12-22 |
| K232338 | Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2023-12-22 |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | FLE | Class II | 2023-12-19 |
| K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | Zibo Kaiyue Mould Technology Co., Ltd. | LZA | Class I | 2023-12-15 |
| DEN230050 | Body Temperature Software (BTS) | Fitbit, LLC | QZA | Class II | 2023-12-15 |
| K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | FRC | Class II | 2023-12-15 |
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation | OVY | Class II | 2023-12-15 |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | LHI | Class II | 2023-12-14 |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | FMI | Class II | 2023-12-12 |
| K233222 | Aygün Sterilization Container Systems | Aygun Surgical Instruments Co., Inc. | KCT | Class II | 2023-12-12 |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | Steris | JOJ | Class II | 2023-12-08 |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port | Bard Peripheral Vascular, Inc. | LJT | Class II | 2023-12-08 |
| K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | FRG | Class II | 2023-12-07 |
| K233042 | Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shandong Intco Medical Products Co, Ltd. | LZA | Class I | 2023-12-06 |
| K222057 | THERMOCLICK | T&R BIOFAB CO., Ltd. | FLL | Class II | 2023-12-05 |
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | FPA | Class II | 2023-12-01 |
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2023-12-01 |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | LHI | Class II | 2023-12-01 |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2023-12-01 |
| K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMF | Class II | 2023-11-30 |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | Argon Medical Devices | LJS | Class II | 2023-11-30 |
| K231877 | NavaClick Injection System | Lineage Biomedical, Inc. | FMF | Class II | 2023-11-30 |
| K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | Dehai (Shandong) Medical Gloves, Co., Ltd. | LZA | Class I | 2023-11-28 |
| K230883 | VersaPump Infusion System | Emed Technologies Corporation | PKP | Class II | 2023-11-28 |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | FLE | Class II | 2023-11-27 |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | FMI | Class II | 2023-11-27 |
| K232576 | Medical Nitrile Examination Gloves | Jiangsu Complete Sincerity Medical New Materials Co., Ltd. | LZA | Class I | 2023-11-21 |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | MEG | Class II | 2023-11-21 |
| K232538 | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2023-11-17 |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | Kossan International Sdn Bhd | LZA | Class I | 2023-11-14 |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | Spm Medicare Pvt. , Ltd. | NGT | Class II | 2023-11-09 |
| K222780 | LILY Extension Tube and Needleless Connector | Lily Medical Corporation | FPA | Class II | 2023-11-09 |
| K231519 | Revital Cady | Revital Healthcare (Epz) Limited | FMF | Class II | 2023-11-06 |
| K230343 | ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. | FPA | Class II | 2023-11-03 |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2023-11-03 |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems | FRN | Class II | 2023-11-03 |
| K233056 | EpiZact | Guidestar Medical Devices | FMF | Class II | 2023-11-02 |
| K230083 | SAFIRA | Medovate Limited | FRN | Class II | 2023-10-31 |
| K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | Zhonghong Pulin Medical Products Co., Ltd. | LZA | Class I | 2023-10-30 |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | MEG | Class II | 2023-10-27 |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris | JOJ | Class II | 2023-10-27 |
| K231934 | GIA Stapler with Tri-Staple Technology | Covidien | GAG | Class II | 2023-10-27 |
| K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | Zhonghong Pulin Medical Products Co., Ltd. | LZA | Class I | 2023-10-26 |
| K232205 | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set | Vesco Medical, LLC | LZH | Class II | 2023-10-23 |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | Steris | MLR | Class II | 2023-10-20 |
| K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | Shanxi Hongjin Plastic Technology Co., Ltd. | LZA | Class I | 2023-10-20 |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | QYM | Class II | 2023-10-18 |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | MEG | Class II | 2023-10-18 |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2023-10-14 |
| K232070 | Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2023-10-11 |
| K221777 | Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. | FMF | Class II | 2023-10-06 |
| K232055 | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | LHI | Class II | 2023-10-06 |
| K230777 | Patient Examination Gloves | 3A Glove Sdn. Bhd. | LZA | Class I | 2023-10-06 |
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical, Inc. | FMI | Class II | 2023-10-05 |
| K231567 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2023-10-04 |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation | MED | Class II | 2023-10-03 |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | QOI | Class II | 2023-10-03 |
| K232064 | Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) | Isikel Manufacturing, LLC | LZA | Class I | 2023-10-02 |
| K230681 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl | Central Medicare Sdn Bhd | LZA | Class I | 2023-10-02 |
| K231957 | SafeBreak® Vascular | Lineus Medical | QOI | Class II | 2023-09-29 |
| K230847 | Chemotherapy Gloves | 3A Glove Sdn. Bhd. | LZA | Class I | 2023-09-29 |
| K231792 | VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2023-09-28 |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) | Hantech Medical Device Co., Ltd. | NGT | Class II | 2023-09-27 |
| K231888 | BD Texium Needle-Free Syringe | Care Fusion | FMF | Class II | 2023-09-25 |
| K232571 | CATHTONG II PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2023-09-22 |
| K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2023-09-22 |
| K232594 | CATHTONG II PICC Catheter | L&Z Us, Inc. | LJS | Class II | 2023-09-22 |
| K223214 | Powder-Free Nitrile Examination Gloves | Global Protection Corp. | LZA | Class I | 2023-09-21 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited | FOZ | Class II | 2023-09-21 |
| K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMI | Class II | 2023-09-20 |
| K223835 | MA-40, MA-112 | Medify Air, LLC | FRF | Class II | 2023-09-18 |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | QNQ | Class II | 2023-09-15 |
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC | FOZ | Class II | 2023-09-15 |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | MMK | Class II | 2023-09-14 |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | FMI | Class II | 2023-09-14 |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | FLE | Class II | 2023-09-13 |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | OVY | Class II | 2023-09-11 |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | FMI | Class II | 2023-09-08 |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Syntex Healthcare Products Co., Ltd. | LZA | Class I | 2023-09-08 |
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | FMI | Class II | 2023-09-08 |
| K230372 | VitreJect Syringe | Ocuject, LLC | QLY | Class II | 2023-09-08 |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. | FMF | Class II | 2023-09-08 |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | FMI | Class II | 2023-09-08 |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | FRG | Class II | 2023-09-07 |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | FRG | Class II | 2023-09-07 |
| DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | QXJ | Class II | 2023-09-01 |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. | KPE | Class II | 2023-09-01 |
| K232353 | Powder Free Nitrile Examination Gloves (Black) | Shanxi Hongjin Plastic Technology Co., Ltd. | LZA | Class I | 2023-08-31 |
| K231626 | OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. | FOZ | Class II | 2023-08-31 |
| K231435 | KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Kimberly-Clark Corporation | LZA | Class I | 2023-08-28 |
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | FLL | Class II | 2023-08-25 |
| K231255 | NovoFine® Plus | Novo Nordisk, Inc. | FMI | Class II | 2023-08-25 |
| K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | FRG | Class II | 2023-08-25 |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | MRH | Class II | 2023-08-25 |
| K223606 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | PHC | Class II | 2023-08-24 |
| K223607 | Plum Duo Infusion System | Icu Medical, Inc. | FRN | Class II | 2023-08-24 |
| K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. | LZA | Class I | 2023-08-24 |
| K231604 | Instrument Case | Cochlear Americas | KCT | Class II | 2023-08-24 |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | Covidien | GAG | Class II | 2023-08-16 |
| K231491 | TA Stapler and Loading Unit with DST Series Technology | Covidien | GAG | Class II | 2023-08-16 |
15,723 clearances in the General Hospital panel. Data: openFDA.