Cleared Traditional

STERILE SUGICAL GOWN PACK (K914563) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914563 · Assured Surgical Products, Inc. · General Hospital
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Jan 1992
Decision
87d
Days
Class 2
Risk

K914563 is an FDA 510(k) clearance for the STERILE SUGICAL GOWN PACK. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Assured Surgical Products, Inc. (San Bernardino, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Assured Surgical Products, Inc. devices

Submission Details

510(k) Number K914563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 15, 1991
Decision Date January 10, 1992
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FYA Gown, Surgical

All 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K914563.
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993
STERILE CONVERTOR SAFECARE GOWN AND DRAPE
K920837 · Baxter Healthcare Corp · May 1992
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · Baxter Healthcare Corp · Feb 1990
THEATRE GOWNS
K872758 · Smith & Nephew, Inc. · Jul 1987