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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K250011
Device Name Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
Applicant
Turbett Surgical
245 Summit Pt. Dr.
Suite 2a
Henrietta,  NY  14467
Applicant Contact Melissa Conley
Correspondent
Turbett Surgical
245 Summit Pt. Dr.
Suite 2a
Henrietta,  NY  14467
Correspondent Contact Melissa Conley
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/02/2025
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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