Cleared Traditional

K880208 - INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION

K880208 · Dresser Argus, Inc. · General & Plastic Surgery device
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Apr 1988
Decision
88d
Days
-
Risk

K880208 is an FDA 510(k) clearance for the INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dresser Argus, Inc. (Brooklyn, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 88 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 Dresser Argus, Inc. devices

FDA 510(k) Submission Details - K880208

510(k) Number K880208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date April 12, 1988
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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