Cleared Traditional

K023025 - SELF SEAL STERILIZATION POUCH

K023025 is an FDA 510(k) clearance for SELF SEAL STERILIZATION POUCH, manufactured by Granton Medical , Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K023025 · Granton Medical , Ltd. · General Hospital
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Mar 2003
Decision
174d
Days
Class 2
Risk

K023025 is an FDA 510(k) clearance for the SELF SEAL STERILIZATION POUCH. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Granton Medical , Ltd. (Crofton, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 174 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.

FDA 510(k) Submission Details - K023025

510(k) Number K023025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date March 04, 2003
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 310
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K023025.
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
K023614 · Case Medical, Inc. · Apr 2003
STERILIZATION CASES AND TRAYS
K023658 · Carr Metal Products, Inc. · Mar 2003
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI
K030853 · Case Medical, Inc. · Mar 2003
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · Allegiance Healthcare Corp. · Aug 2002
RE-USABLE STERILIZATION POUCH / BAG
K013715 · Quality Products of Montana · Apr 2002
K023025 · SELF SEAL STERILIZATION POUCH
Download PDF Granton Medical , Ltd.