Cleared Traditional

K092682 - GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-S...

K092682 is the FDA 510(k) clearance for GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-S... by Gyrus Acmi, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K092682 · Gyrus Acmi, Inc. · General Hospital
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Dec 2009
Decision
101d
Days
Class 2
Risk

K092682 is an FDA 510(k) clearance for the GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on December 11, 2009 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gyrus Acmi, Inc. devices

Submission Details

510(k) Number K092682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date December 11, 2009
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 160
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