Cleared Traditional

K760554 - APPAREL

K760554 is the FDA 510(k) clearance for APPAREL by Surgikos, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K760554 · Surgikos, Inc. · General Hospital
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Nov 1976
Decision
73d
Days
Class 2
Risk

K760554 is an FDA 510(k) clearance for the APPAREL, BARRIER SCRUB. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976 after a review of 73 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 Surgikos, Inc. devices

Submission Details

510(k) Number K760554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1976
Decision Date November 12, 1976
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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.