Cleared Traditional

K870314 - WHITE PLUME GAUZE SPONGE

K870314 · China National Medicines & Health Prod. I/E Corp. · General & Plastic Surgery device
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Feb 1987
Decision
27d
Days
-
Risk

K870314 is an FDA 510(k) clearance for the WHITE PLUME GAUZE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by China National Medicines & Health Prod. I/E Corp. (Suite 500, Washington, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 China National Medicines & Health Prod. I/E Corp. devices

FDA 510(k) Submission Details - K870314

510(k) Number K870314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date February 24, 1987
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 157
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K871438 · Fraass Survival Systems, Inc. · May 1987
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K864175 · Fraass Survival Systems, Inc. · Nov 1986
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K863932 · Fraass Survival Systems, Inc. · Oct 1986
BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES
K863713 · Fraass Survival Systems, Inc. · Oct 1986