Cleared Traditional

K881176 - STERILE ESMARCH BANDAGE

K881176 is an FDA 510(k) clearance for STERILE ESMARCH BANDAGE, manufactured by Spectrum/Hydro-Med Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K881176 · Spectrum/Hydro-Med Products, Inc. · General & Plastic Surgery device
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Apr 1988
Decision
24d
Days
Class 1
Risk

K881176 is an FDA 510(k) clearance for the STERILE ESMARCH BANDAGE. Classified as Tourniquet, Nonpneumatic (product code GAX), Class I - General Controls.

Submitted by Spectrum/Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on April 11, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5900 - the FDA general and plastic surgery 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 Spectrum/Hydro-Med Products, Inc. devices

FDA 510(k) Submission Details - K881176

510(k) Number K881176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date April 11, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

GAX Device Classification - Class 1, General Controls

Product Code GAX Tourniquet, Nonpneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAX Tourniquet, Nonpneumatic

All 7
Devices cleared under the same product code (GAX) and FDA review panel - the closest regulatory comparables to K881176.
DEGANIA SILICONE TOURNIQUET
K875092 · Degania Silicone , Ltd. · Jan 1988
UNIVERSAL TOURNIQUET
K873928 · Dryden Corp. · Oct 1987
VELCRO TOURNIQUET
K853537 · Cp Medical · Sep 1985
TOURNIQUET
K851482 · Polymer Technology Corp. · Apr 1985
LATEX PENROSE DRAIN TUBING
K821700 · Abco Dealers, Inc. · Jun 1982
CONPHAR VELCRO TOUNIGUER
K803142 · Conphar, Inc. · Jan 1981