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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K233653
Device Name Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
Applicant
Peregrine Surgical, LLC
51 Britain Dr.
New Britain,  PA  18901
Applicant Contact Melissa DeHass
Correspondent
Peregrine Surgical, LLC
51 Britain Dr.
New Britain,  PA  18901
Correspondent Contact Melissa DeHass
Regulation Number876.1500
Classification Product Code
MPA  
Date Received11/14/2023
Decision Date 08/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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