Cleared Traditional

K990567 - GLOBAL HEALTHCARE SELF-SEALING STERILIZ...

K990567 is an FDA 510(k) clearance for GLOBAL HEALTHCARE SELF-SEALING STERILIZ..., manufactured by Global Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K990567 · Global Healthcare, Inc. · General Hospital
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Apr 1999
Decision
41d
Days
Class 2
Risk

K990567 is an FDA 510(k) clearance for the GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Global Healthcare, Inc. (Atlanta, US). The FDA issued a Cleared decision on April 5, 1999 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Global Healthcare, Inc. devices

FDA 510(k) Submission Details - K990567

510(k) Number K990567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date April 05, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 129d · This submission: 41d
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 150
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K990567.
ALLEGIANCE GENESIS CONTAINER SYSTEM
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BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
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BIOSHIELD EXPRESS STERILIZATION WRAP
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SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996