Cleared Traditional

Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)

K233653 · Peregrine Surgical, LLC · Ophthalmic

Aug 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K233653 is an FDA 510(k) clearance for the Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00), a Endoilluminator (Class II — Special Controls, product code MPA), submitted by Peregrine Surgical, LLC (New Britain, US). The FDA issued a Cleared decision on August 5, 2024, 265 days after receiving the submission on November 14, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K233653 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2023
Decision Date	August 05, 2024
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF