Product code FRG

Current FDA Classification

Device name
Wrap, Sterilization
Medical specialty
General Hospital
Device class
2
Regulation number
880.6850
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.2026-01-28
K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.2025-12-12
K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.2025-10-31
K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.2025-06-26
K250321GCI Sterilization WrappersGeorge Courey, Inc.2025-06-06
K243721Self Sealing Sterilization PouchesWellmed Dental Medical Supply Co., Ltd.2025-04-25
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)Turbett Surgical2025-04-04
K241565Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd.2025-02-24
K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.2025-02-21
K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd.2025-02-21
K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever2024-11-04
K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2024-10-16
K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.2024-10-07
K241123Perpak™ Sterilization Tyvek PouchKm Corp.2024-09-18
K234132Medline Reusable Sterilization WrappersMedline Industries, LP2024-09-17
K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapO&M Halyard, Inc.2024-09-16
K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)O&M Halyard, Inc.2024-08-07
K240862Medicom Sterilization WrapMedicom Group, Inc.2024-06-21
K232625Steriking® Pouch for Robotic InstrumentsWipak OY2024-06-07
K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.2024-05-24
K233262Dukal SMS Sterilization WrapDukal, LLC2024-03-22
K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC2023-12-07
K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY2023-09-07
K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY2023-09-07
K223600Sterilization WrapWuhan Zonsen Medical Products Co., Ltd.2023-08-25
K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation2023-08-07
K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.2023-05-09
K222151Sterilization WrapKenpax International Limited2023-03-23
K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd.2023-02-13
K221379Steriking LT-Blueline Pouches with TyvekWipak OY2023-01-04

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