Cleared Traditional

STRUVA & MEDI (K811173) - FDA 510(k) Clearance

Class I General Hospital device.

K811173 · Weco · General Hospital
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Jun 1981
Decision
51d
Days
Class 1
Risk

K811173 is an FDA 510(k) clearance for the STRUVA & MEDI. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Weco (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - 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 Weco devices

Submission Details

510(k) Number K811173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date June 18, 1981
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
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 - FQM Bandage, Elastic

All 8
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K811173.
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE
K831551 · Fred Sammons, Inc. · Jun 1983
SOF-BAND HIGH STRETCH BANDAGES
K810137 · Johnson & Johnson Professionals, Inc. · Feb 1981
ROLL STRETCH GAUZE
K802991 · Abco Dealers, Inc. · Dec 1980
ELASTIC GAUZE
K802992 · Abco Dealers, Inc. · Dec 1980
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979