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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K261670
Device Name Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads
Applicant
Poly Medicure Limited
Pa 010-018, 010-019, Mahindra World City (Jaipur) Ltd.
Multi Product Sez
Jaipur,  IN 302237
Applicant Contact Ramdas Sharma
Correspondent
GSA2 Group, LLC
8049 Hayes St. N. E.
Spring Lake Park,  MN  55432
Correspondent Contact Sunita Teekasingh
Regulation Number876.5130
Classification Product Code
LJH  
Subsequent Product Code
HRX  
Date Received05/20/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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