Cleared Traditional

K923798 - SURGICAL GOWN PACK

K923798 is an FDA 510(k) clearance for SURGICAL GOWN PACK, manufactured by Central Georgia Ancillary Health Systems. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K923798 · Central Georgia Ancillary Health Systems · General Hospital
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Jan 1993
Decision
191d
Days
Class 2
Risk

K923798 is an FDA 510(k) clearance for the SURGICAL GOWN PACK. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Central Georgia Ancillary Health Systems (Macon, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 191 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Central Georgia Ancillary Health Systems devices

FDA 510(k) Submission Details - K923798

510(k) Number K923798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date January 27, 1993
Days to Decision 191 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
62d slower than avg
Panel avg: 129d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 193
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K923798.
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
ULCER WOUND TRAY
K922828 · Ulti-Med Intl., Inc. · Sep 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · Trinity Laboratories, Inc. · Aug 1992