Cleared Traditional

K030684 - SCOPE GUARD PROTECTIVE SHEATH

K030684 is an FDA 510(k) clearance for SCOPE GUARD PROTECTIVE SHEATH, manufactured by Acmi Corporation. The device is a Class 2 Gastroenterology & Urology device with product code OCU cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K030684 is an FDA 510(k) clearance for the SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH. Classified as Endoscopic Storage Cover (product code OCU), Class II - Special Controls.

Submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on June 3, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acmi Corporation devices

FDA 510(k) Submission Details - K030684

510(k) Number K030684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCU Device Classification - Class 2, Special Controls

Product Code OCU Endoscopic Storage Cover
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCU Endoscopic Storage Cover

Devices cleared under the same product code (OCU) and FDA review panel - the closest regulatory comparables to K030684.
Andorate Universal Endoscope Tip Guard
K202838 · Ga Health Company Limited · Mar 2021
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715 · STERIS Corporation · Jan 2020
Scope ProTech
K191011 · Meditech Endoscopy, Ltd. · May 2019
ENDOBOOT
K951104 · United States Endoscopy Group, Inc. · Apr 1995