FRG — Wrap, Sterilization Class II

FDA Device Classification

Classification Details

Product Code
FRG
Device Class
Class II
Regulation Number
880.6850
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251347sterivic medical coSterilization Pouch/RollJanuary 28, 2026
K251177guangdong maidi medical coSelf-Seal Sterilization Pouch and RollDecember 12, 2025
K250306propper manufacturing coChex-All Sterilization Pouches and TubesOctober 31, 2025
K243179yichang xinxin paper products coSterilization Pouch and RollJune 26, 2025
K250321george coureyGCI Sterilization WrappersJune 6, 2025
K243721wellmed dental medical supply coSelf Sealing Sterilization PouchesApril 25, 2025
K250011turbett surgicalTurbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120April 4, 2025
K241565anqing clean dental instrument technology coSterilization Package/ReelFebruary 24, 2025
K243431medicom asia-pacific holdings ltd. taiwan branchMedicom Sterilization Pouch and ReelFebruary 21, 2025
K242898shanghai jianzhong medical packaging coSterilization Pouches and ReelsFebruary 21, 2025
K240438comercializadora breverCDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (4November 4, 2024
K242839shenzhen safesecure medical infection control tech co.Safe Secure Sterilization Pouches and RollsOctober 16, 2024
K242208primed medical productsPRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)October 7, 2024
K241123kmPerpak™ Sterilization Tyvek PouchSeptember 18, 2024
K234132medline industriesMedline Reusable Sterilization WrappersSeptember 17, 2024
K234050o and m halyardHALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap,September 16, 2024
K240330o and m halyardHALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* SterilizatiAugust 7, 2024
K240862medicom groupMedicom Sterilization WrapJune 21, 2024
K232625wipakSteriking® Pouch for Robotic InstrumentsJune 7, 2024
K233777primed medical productsPRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)May 24, 2024