Medline ReNewal Reprocessed Endopath Endoscopic Instruments— 510(k) K152313

Name: FDA 510(k) clearance K152313
Creator: U.S. Food and Drug Administration
Published: 2016-01-06

Substantially Equivalent

Surgical Instrument Services and Savings, Inc.

FDA 510(k) clearance K152313 for Medline ReNewal Reprocessed Endopath Endoscopic Instruments, Substantially Equivalent on 2016-01-06. Applicant: Surgical Instrument Services and Savings, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Instrument Services and Savings, Inc.
Product code: Code NUJ
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2015-08-17
Decision date: 2016-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

Download summary PDF View on FDA.gov ↗

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