Cleared Traditional

K760937 - BARRIER NEURO SHEET

K760937 is the FDA 510(k) clearance for BARRIER NEURO SHEET by Surgikos, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K760937 · Surgikos, Inc. · General Hospital
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Dec 1976
Decision
50d
Days
Class 2
Risk

K760937 is an FDA 510(k) clearance for the BARRIER NEURO SHEET. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 21, 1976 after a review of 50 days - a notably fast clearance 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: 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 K760937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1976
Decision Date December 21, 1976
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K760937.
TOWEL, DRAPE, BOUNDARY
K780036 · Procter & Gamble Mfg. Co. · Jan 1978
SURGICAL HEAD DRAPE, DISP.
K771136 · Procter & Gamble Mfg. Co. · Jul 1977
UNDER BOTTOCKS DRAPE
K760997 · C.R. Bard, Inc. · Mar 1977
BOUNDARY FABRIC III SURGICAL DRAPE
K760932 · Procter & Gamble Mfg. Co. · Nov 1976
STERILE STOCKINETTE
K760867 · Abco Dealers, Inc. · Nov 1976