Cleared Traditional

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

K030684 · Acmi Corporation · Gastroenterology & Urology
Jun 2003
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K030684 is an FDA 510(k) clearance for the SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH, a Endoscopic Storage Cover (Class II — Special Controls, product code OCU), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on June 3, 2003, 90 days after receiving the submission on March 5, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K030684 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2003
Decision Date June 03, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code OCU — Endoscopic Storage Cover
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization.