Cleared Traditional

K800082 - STORZ SUPER SORB MICRO EYE SPONGE (FDA 510(k) Clearance)

K800082 · Storz Instrument Co. · General & Plastic Surgery device
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Feb 1980
Decision
22d
Days
-
Risk

K800082 is an FDA 510(k) clearance for the STORZ SUPER SORB MICRO EYE SPONGE. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Storz Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1980 after a review of 22 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 Storz Instrument Co. devices

Submission Details

510(k) Number K800082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date February 05, 1980
Days to Decision 22 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
92d faster than avg
Panel avg: 114d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -