Cleared Traditional

K102970 - GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT

K102970 is an FDA 510(k) clearance for GYRUS ACMI CYBER WAND-STERILIZATION TRA..., manufactured by Gyrus Acmi, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K102970 · Gyrus Acmi, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2011
Decision
226d
Days
Class 2
Risk

K102970 is an FDA 510(k) clearance for the GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT. 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 May 20, 2011 after a review of 226 days - an extended review cycle.

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

FDA 510(k) Submission Details - K102970

510(k) Number K102970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2010
Decision Date May 20, 2011
Days to Decision 226 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
97d slower than avg
Panel avg: 129d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 227
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K102970.
OLYMPUS INSTRUMENT TRAY
K110748 · Olympus Winter & Ibe GmbH · Feb 2012
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
K110682 · Case Medical, Inc. · Jul 2011
STAT-MAT MINOR
K110500 · Macpherson Medical, Inc. · Jun 2011
STERILIZATION MATS
K103226 · STERIS Corporation · Feb 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · Entellus Medical, Inc. · Feb 2011
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · Skeletal Dynamics, LLC · Dec 2010